{"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","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)"},"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,"createdAt":"2026-06-03T23:33:00.720Z","updatedAt":"2026-06-04T02:39:58.754Z","jsonLd":{"@context":"https://schema.org","@type":"Product","@id":"https://registry.deploy.report/models/happy-ring","url":"https://registry.deploy.report/models/happy-ring","name":"Happy Ring","alternateName":["Happy Ring","Happy Health 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.","identifier":"2af2d126-5e1a-4636-ac6f-cc5e0f8bbe1f","category":"biometric","publisher":{"@id":"https://deploy.report/#organization"}}}