Regulatory filing

K143690 (us_fda)

FDA 510(k) K143690 for Ekso/Ekso GT. EksoNR is FDA-cleared for stroke, acquired brain injury, MS, and spinal cord injury. Only exoskeleton with ABI and MS clearance.

fda 510k · cleared · decided 2015-01-01

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Key facts

Jurisdiction: us_fda
Filing type: fda 510k
Status: cleared
Filing number: K143690
Filing date: 2015-01-01
Decision date: 2015-01-01
Verification posture: verified
Cap-flag notes: Only exoskeleton with ABI and MS clearance.

Applicant

Ekso Bionics

Covered models (1)

EksoNR

Sources (1)

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K143690

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Identity

47401258-bd28-4b82-8d92-e337bb17b3c1