QUANTUM BLAST
FDA 510(k) clearance K011993 · decided 2001-07-13
Clearance details
- K-number
- K011993
- Device name
- QUANTUM BLAST
- Applicant
- Pride Mobility Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-06-26
- Decision date
- 2001-07-13
- Days to decision
- 17 days
- Clearance type
- Special
- 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 |
|---|---|---|
| Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software Versi recall (Z-2844-2026) | Pride Mobility Products Corp. | 2026-07-31 |
| Brand Name: Quantum Rehab Product Name: Quantum Rival Model/Catalog Number: Quantum Rival recall (Z-2853-2026) | Pride Mobility Products Corp. | 2026-07-31 |
| Q-Logic Controller Software used on the following power wheelchairs: Q6000, Q6000XL, Q6000 recall (Z-1776-2008) | Pride Mobility Products Corp | 2008-08-27 |