HANDMASTER
FDA 510(k) clearance K031900 · decided 2003-08-08
Clearance details
- K-number
- K031900
- Device name
- HANDMASTER
- Applicant
- Ness-Neuromuscular Electrical Stimulation Systems
- Decision
- Substantially Equivalent
- Date received
- 2003-06-19
- Decision date
- 2003-08-08
- Days to decision
- 50 days
- Clearance type
- Special
- Product code
- GZI
- Device class
- 2
- Regulation number
- 882.5810
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.