EksoNR
FDA 510(k) clearance K220988 · decided 2022-06-09
Clearance details
- K-number
- K220988
- Device name
- EksoNR
- Applicant
- Ekso Bionics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-04-04
- Decision date
- 2022-06-09
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- PHL
- Device class
- 2
- Regulation number
- 890.3480
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Richmond, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.