REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM
FDA 510(k) clearance K111636 · decided 2012-04-03
Clearance details
- K-number
- K111636
- Device name
- REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM
- Applicant
- Gunnell, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-06-13
- Decision date
- 2012-04-03
- Days to decision
- 295 days
- Clearance type
- Traditional
- Product code
- IOR
- Device class
- 1
- Regulation number
- 890.3850
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Millington, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Chenica Gunnell Rehab Series of Wheelchairs (GRSW); Mechanical Wheelchair, Sold as Rehab T recall (Z-0809-2013) | CHENICA INC. | 2013-02-13 |