Neurolutions Upper Extremity Rehabilitation System
FDA 510(k) clearance DEN200046 · decided 2021-04-23
Clearance details
- K-number
- DEN200046
- Device name
- Neurolutions Upper Extremity Rehabilitation System
- Applicant
- Neurolutions, Inc.
- Decision
- Unknown
- Date received
- 2020-07-23
- Decision date
- 2021-04-23
- Days to decision
- 274 days
- Clearance type
- Direct
- Product code
- QOL
- Device class
- 2
- Regulation number
- 890.5420
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Santa Cruz, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.