TMR48
FDA 510(k) clearance K953342 · decided 1995-09-08
Clearance details
- K-number
- K953342
- Device name
- TMR48
- Applicant
- Pride Health Care, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-07-11
- Decision date
- 1995-09-08
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- INO
- Device class
- 2
- Regulation number
- 890.3110
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- West Wyoming, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Lift Chairs. Electric Positioning Chair. recall (Z-0212-05) | Pride Mobility Products Corp | 2004-11-19 |