{"id":"b80b1db0-aab9-4612-b3af-5d7dceb5c952","modelId":"2af2d126-5e1a-4636-ac6f-cc5e0f8bbe1f","versionId":null,"locationId":"f42cb087-b4c0-49ea-97b6-d47fcfa6f304","operatorId":null,"ownerId":null,"slug":"happy-ring-germany-europe","status":"operational","firstSeen":null,"statusChangeReason":null,"contractType":null,"pilotOutcome":null,"endedAt":null,"unitsOnSite":null,"tasksPerformed":null,"shiftStructure":null,"hoursPerDay":null,"siteType":null,"operatorConfirmed":null,"humanSupervisionOnsite":null,"locationPrecisionTier":null,"deploymentScale":null,"siteEnvironment":null,"operatorType":null,"sourceQualityTier":null,"manufacturerSerial":null,"reviewStatus":"unreviewed","sources":[],"notes":"Commercial product — available for purchase in this market.","keyFacts":[],"reviewNote":null,"exposureHours":null,"deploymentMilesEstimate":null,"exposureBasis":null,"customerSegment":null,"scaleTier":null,"contractValueUsd":null,"contractValueBasis":null,"customerCompanyId":null,"customerExternalName":null,"createdAt":"2026-08-20T04:09:13.094Z","updatedAt":"2026-08-20T04:09:13.094Z","model":{"id":"2af2d126-5e1a-4636-ac6f-cc5e0f8bbe1f","companyId":"676e07ce-5d14-4b02-b991-3f3864e874f5","modelName":"Happy Ring","slug":"happy-ring","description":"Happy Ring is a finger-worn smart ring made by Happy Health Inc of Austin, Texas, and it is recorded in the biometric form factor as the within-cohort genuinely-FDA-cleared sleep-apnea exemplar, the verified counterpoint to uncleared sleep-apnea claims elsewhere in the cohort. Its sensor stack of four LEDs, four electrodes, a three-axis accelerometer, and two temperature sensors yields heart rate, heart-rate variability, blood-oxygen saturation, skin temperature, respiratory rate, activity, and sleep staging, and the value of the device is its cleared sleep-apnea algorithm. It holds two FDA 510(k) clearances: K240236, decided October 8, 2024, for retrospective remote monitoring of physiological parameters in adults at home or in healthcare facilities, and K242224, decided June 18, 2025, a Home Sleep Test that processes ring signals for clinician-interpreted diagnosis of sleep disorders such as obstructive sleep apnea and insomnia in individuals aged twenty-two and older under the direction of a trained healthcare provider. The first clearance is best read as monitoring and the second as diagnosis-facilitating, so the genuinely-FDA-cleared framing holds while the diagnosis is clinician-mediated rather than autonomous, and the registry does not extend the claim beyond the cleared indication. Several cap-flags apply. The widely-cited figure of about ninety-seven percent agreement with gold-standard polysomnography is company-reported and has no peer-reviewed citation found, with the company's own technology page instead stating the softer claim of being ten times more accurate than a watch. Commercial availability is service-gated and thin: the ring is sold only bundled into the clinician-reviewed Happy Sleep home-sleep-test service, which is insurer-billed, rather than as a standalone retail ring with a published consumer price, and the company raised a sixty-million-dollar Series A in August 2022 led by ARCH Venture Partners with no later round surfaced, so it is an early-stage and quiet company; the maturity is recorded as commercial because the cleared service is live and billed, with the cap-flag preventing over-reading the FDA clearance as broad market presence. Finally, marketing references to brain activity or brain biometrics are flagged as marketing-forward because no EEG sensor is itemized on the spec page. The chief executive is Dustin Freckleton, MD.","formFactor":"biometric","industryVertical":null,"environment":null,"maturityStage":"commercial","lifecycleState":"active","supersededByModelId":null,"specs":{"notes":[{"label":"INCLUDE (biometric-primary + cleared AI algorithm)","value":"Finger PPG/temperature/SpO2/accelerometer biometric-primary device whose value is the cleared sleep-apnea algorithm. Would it exist without the AI? Yes-but-degraded (raw sensor logger). Clearly biometric form_factor."},{"label":"Verified-vs-claimed COUNTERPOINT to RingConn (the editorial anchor)","value":"Happy Ring is the within-cohort GENUINELY-FDA-CLEARED sleep-apnea exemplar: two real, precisely-dated 510(k) clearances (K240236, K242224) for clinician-mediated diagnosis support. This is the verified counterpoint to RingConn, whose sleep-apnea/AHI feature is NOT FDA-cleared and whose 'FDA-cleared' framing was aggregator-drift conflation. Note the precise scope: K242224 facilitates clinician-interpreted diagnosis (a Home Sleep Test under provider direction), NOT autonomous device diagnosis - do not extend beyond the cleared indication."},{"label":"Cap-flag: 97% PSG agreement = COMPANY-REPORTED","value":"The ~97% agreement-to-gold-standard-polysomnography figure appears in Happy Health press releases / happysleep.com only; no peer-reviewed publication found. Treat as company-reported, not peer-reviewed. (happysleep.com/tech itself states the softer '10x more accurate than a watch.')"},{"label":"Cap-flag: commercial state is SERVICE-GATED / limited","value":"Maturity=commercial because the FDA-cleared service is live and insurer-billed, but availability is thin: no standalone consumer retail sale, no published consumer price, service-gated through the Happy Sleep home-sleep-test offering; $60M Series A (Aug 2022) with no later round surfaced -> early-stage / quiet company. Tier reflects the cleared live service; the cap-flag prevents over-reading FDA clearance as broad market presence."},{"label":"Cap-flag: 'brain biometrics' marketing","value":"Marketing references 'brain activity / brain biometrics,' but no EEG sensor is itemized on the spec page (4 LEDs / 4 electrodes / accelerometer / 2 temp sensors). Treat 'brain biometrics' as marketing-forward, not substantiated by named hardware."},{"label":"Re-verify 2026-06-03","value":"The 'quiet since 2022' framing is now STALE: Happy Health is commercially ACTIVE. The Happy Sleep service is live across 48 US states, in-network with major insurers (Cigna/Aetna/UnitedHealthcare/BCBS/Medicare) plus a self-pay option; 2026 distribution partnerships have surfaced - OpenLoop (Apr 14 2026, national telehealth network) and EnsoData (EnsoSleep PPG SaMD integration); headcount ~244 (Feb 2026, aggregator-sourced). Availability remains SERVICE-GATED (sold bundled in the insurer-billed/self-pay Happy Sleep diagnostic, NOT standalone retail; no published ring price) - confirmed-current. NO new funding round since the $60M Series A (Aug 2022) - verified-absent. No distress / wind-down signals."}],"specs":"Happy Ring: finger-worn smart ring. Sensors: 4 LEDs, 4 electrodes, 3-axis accelerometer, 2 temperature sensors -> heart rate, HRV, SpO2, skin temperature, respiratory rate, activity, sleep staging. Cleared sleep-apnea algorithm is the regulatory substance. Two FDA 510(k) clearances: K240236 (Oct 8 2024) = retrospective remote MONITORING of physiological parameters in adults at home or in healthcare facilities; K242224 (Jun 18 2025) = Home Sleep Test that processes ring signals for clinician-interpreted DIAGNOSIS of sleep disorders such as obstructive sleep apnea and insomnia, ages 22+, under direction of a trained healthcare provider. Company: Happy Health Inc (Austin TX); CEO Dustin Freckleton MD; $60M Series A (Aug 2022, ARCH Venture Partners), no later round surfaced. Distribution: sold ONLY bundled into the clinician-reviewed 'Happy Sleep' home-sleep-test service (insurer-billed), NOT a standalone retail ring; no published consumer price.","formFactor":"biometric (biometric-primary smart ring; FDA-cleared sleep-apnea / sleep-disorder DIAGNOSIS support via clinician-reviewed home sleep test)","fda_clearance":{"source":"https://happy ring.io/","status":"none","details":"No FDA clearance. Stress and mood tracking via HRV. Pre-order stage as of 2024; limited commercial availability.","audited_at":"2026-06-07","source_name":"Happy Health","health_claim":"Mental wellness and stress management. Wellness-only; early-stage product with unverified scale.","verification_posture":"verified"}},"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K242224","title":"FDA 510(k) K242224: Happy Ring Home Sleep Test (decision Jun 18 2025; facilitates at-home diagnosis of OSA/insomnia, ages 22+, under clinician direction)","sourceName":"FDA 510(k) database"},{"url":"https://aasm.org/fda-clears-happy-ring-by-happy-health/","title":"FDA clears Happy Ring (first clearance K240236, Oct 8 2024; retrospective remote monitoring of physiological parameters)","sourceName":"American Academy of Sleep Medicine"},{"url":"https://www.biospace.com/press-releases/happy-ring-earns-second-fda-clearance","title":"Happy Ring earns second FDA clearance (Home Sleep Test; sold via clinician-reviewed Happy Sleep home-sleep-test service; insurer-covered)","sourceName":"BioSpace / PRNewswire"},{"url":"https://happysleep.com/tech","title":"Happy Ring technology (4 LEDs, 4 electrodes, 3-axis accelerometer, 2 temperature sensors; HR/HRV/SpO2/temperature/respiratory rate/sleep staging)","sourceName":"Happy Health (official)"},{"url":"https://www.finsmes.com/2022/08/happy-health-raises-60m-in-series-a-funding.html","title":"Happy Health raises $60M Series A (Aug 2022, led by ARCH Venture Partners; Austin TX; CEO Dustin Freckleton MD)","sourceName":"FinSMEs"},{"url":"https://openloophealth.com/news/openloop-expands-into-sleep-diagnostis-with-happy-sleep","title":"OpenLoop expands into sleep diagnostics with Happy Sleep (Apr 14 2026; national telehealth distribution)","sourceName":"OpenLoop Health"},{"url":"https://sleepreviewmag.com/sleep-diagnostics/home-testing/home-apnea-testing/happy-ring-maker-ensodata-offer-home-sleep-testing-solution/","title":"Happy Ring maker + EnsoData offer home sleep testing solution (EnsoSleep PPG integration)","sourceName":"Sleep Review"}],"aliases":["Happy Ring","Happy Health Ring"],"collisionRisk":"low","reviewNote":null,"manufacturerTermForTeleop":null,"keyFacts":[{"label":"Sensor suite","value":"4 LEDs, 4 electrodes, 3-axis accelerometer, 2 temperature sensors"},{"label":"FDA clearance","value":"Two FDA 510(k) clearances: K240236 (Oct 8 2024) and K242224 (Jun 18 2025)"},{"label":"Funding","value":"$60M Series A (Aug 2022, ARCH Venture Partners)"},{"label":"Headcount","value":"~244 (Feb 2026, aggregator-sourced)"},{"label":"Distribution","value":"Sold only bundled into clinician-reviewed Happy Sleep home-sleep-test service; no standalone retail price"}],"createdAt":"2026-06-03T23:33:00.720Z","updatedAt":"2026-06-28T16:50:42.925Z","unitsInFieldClaimed":null,"unitsInFieldVerified":null,"unitsManufacturedClaimed":null,"unitsManufacturedVerified":null,"unitsAsOf":null,"unitsSource":null,"salesModel":null,"priceUndisclosedSince":null,"autonomyClass":null,"autonomyStatement":null,"autonomyStatementSource":null,"demoForensics":null,"exportControlClass":null,"minCommitment":null,"warrantyTerms":null,"serviceModel":null,"productionRateClaimed":null,"productionRateEvidenced":null,"teleopRatioDisclosed":null,"interventionRateDisclosed":null,"company":{"id":"676e07ce-5d14-4b02-b991-3f3864e874f5","name":"Happy Health","slug":"happy-health","description":"US health-wearables company (Austin TX) making the Happy Ring, a smart ring with two FDA 510(k) clearances for remote physiological monitoring and clinician-interpreted at-home sleep-disorder diagnosis; sold via the insurer-billed Happy Sleep home-sleep-test service.","status":"private ($60M Series A, Aug 2022, ARCH Venture Partners)","founded":null,"hq":"Austin, Texas, USA","hqLat":30.2711286,"hqLng":-97.7436995,"hqGeocodedAt":"2026-08-05T14:32:19.231Z","hqAddress":null,"hqPrecision":null,"website":"happyhealthyhippieco.com","fundingTotal":"60000000","type":"both","reviewStatus":"reviewed","lifecycleState":"active","supersededByCompanyId":null,"sources":[{"url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K242224","title":"FDA 510(k) K242224: Happy Ring Home Sleep Test (decision Jun 18 2025; facilitates at-home diagnosis of OSA/insomnia, ages 22+, under clinician direction)","sourceName":"FDA 510(k) database"},{"url":"https://aasm.org/fda-clears-happy-ring-by-happy-health/","title":"FDA clears Happy Ring (first clearance K240236, Oct 8 2024; retrospective remote monitoring of physiological parameters)","sourceName":"American Academy of Sleep Medicine"},{"url":"https://www.biospace.com/press-releases/happy-ring-earns-second-fda-clearance","title":"Happy Ring earns second FDA clearance (Home Sleep Test; sold via clinician-reviewed Happy Sleep home-sleep-test service; insurer-covered)","sourceName":"BioSpace / PRNewswire"}],"keyFacts":[{"label":"Product","value":"Happy Ring (FDA 510(k) K240236 monitoring + K242224 Home Sleep Test diagnosis support); sold via clinician-reviewed Happy Sleep service, insurer-billed."},{"label":"Editorial","value":"Genuinely-FDA-cleared sleep-apnea exemplar = verified counterpoint to RingConn's uncleared AHI."},{"label":"Company type","value":"US health-wearables company"},{"label":"Form factor","value":"Smart ring"},{"label":"FDA clearance indication","value":"Remote physiological monitoring"}],"aliases":["Happy Health Inc","Happy Ring","Happy Sleep"],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"factoryLocations":null,"manufacturingCapacity":null,"orgType":null,"burnSignal":null,"litigationEvents":null,"insurancePostureDisclosed":null,"unitEconomicsDisclosed":null,"tickerSymbol":null,"stockExchange":null,"secCik":null,"revenueUsd":null,"revenueBasis":null,"revenueAsOf":null,"employeeCount":null,"employeeCountBasis":null,"employeeCountAsOf":null,"marketCapUsd":null,"marketCapAsOf":null,"marketCapSource":null,"createdAt":"2026-06-03T23:32:59.941Z","updatedAt":"2026-08-05T14:42:26.859Z"}},"version":null,"location":{"id":"f42cb087-b4c0-49ea-97b6-d47fcfa6f304","name":"Germany, Europe","slug":"germany-europe","kind":"country","parentLocationId":null,"region":null,"lat":null,"lng":null,"reviewStatus":"unreviewed","aliases":[],"collisionRisk":"high","reviewNote":null,"createdAt":"2026-08-20T04:07:01.358Z","updatedAt":"2026-08-20T04:07:01.358Z"},"operator":null,"owner":null,"derived":{"trustTier":"unverified","currentPosture":null},"jsonLd":{"@context":"https://schema.org","@type":"Event","@id":"https://registry.deploy.report/deployments/happy-ring-germany-europe","url":"https://registry.deploy.report/deployments/happy-ring-germany-europe","name":"Happy Ring at Germany, Europe","identifier":"b80b1db0-aab9-4612-b3af-5d7dceb5c952","location":{"@type":"Place","@id":"https://registry.deploy.report/locations/germany-europe","name":"Germany, Europe"},"organizer":{"@type":"Organization","@id":"https://registry.deploy.report/companies/happy-health","name":"Happy Health"},"about":{"@type":"Product","@id":"https://registry.deploy.report/models/happy-ring","name":"Happy Ring"},"publisher":{"@id":"https://deploy.report/#organization"}},"framework_metadata":{"framework_schema_version":"0.1.0","verification_status":"unreviewed","maturity_stage":"commercial","lifecycle_state":"active","architectural_position":{"cohort":"biometric","sub_cohorts":[]},"within_cohort_verified_vs_claimed_pair":null,"cap_flags":[],"verification_depth":{"sources_count":0,"primary_source_types":[]}}}