EXTERNAL FUNCTIONAL NEUROMUSCULAR STIMULATOR
FDA 510(k) clearance K974514 · decided 1998-02-06
Clearance details
- K-number
- K974514
- Device name
- EXTERNAL FUNCTIONAL NEUROMUSCULAR STIMULATOR
- Applicant
- Neuromotion, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-12-01
- Decision date
- 1998-02-06
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- GZI
- Device class
- 2
- Regulation number
- 882.5810
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Edmonton, Alberta, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.