SYNERGY ULTIMATE
FDA 510(k) clearance K041346 · decided 2004-09-08
Clearance details
- K-number
- K041346
- Device name
- SYNERGY ULTIMATE
- Applicant
- Pride Mobility Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 2004-05-20
- Decision date
- 2004-09-08
- Days to decision
- 111 days
- Clearance type
- Traditional
- Product code
- ITI
- Device class
- 2
- Regulation number
- 890.3860
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Exeter, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| TRU-Balance 3 Power Positioning Systems, TB3 Lift/Tilt/Recline (Gen 1). Mobility Medical D recall (Z-0942-2017) | Pride Mobility Products Corp | 2017-01-03 |