TENS-IT, FITTRONIC II, (MORE LATER)
FDA 510(k) clearance K946018 · decided 1995-11-09
Clearance details
- K-number
- K946018
- Device name
- TENS-IT, FITTRONIC II, (MORE LATER)
- Applicant
- Ems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-12-09
- Decision date
- 1995-11-09
- Days to decision
- 335 days
- Clearance type
- Traditional
- Product code
- GZL
- Device class
- 2
- Regulation number
- 882.1330
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Pen Valley, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.