PEDIATRIC FOLDING WHEELCHAIR
FDA 510(k) clearance K130644 · decided 2013-10-16
Clearance details
- K-number
- K130644
- Device name
- PEDIATRIC FOLDING WHEELCHAIR
- Applicant
- Columbia Medical Mfg, LLC
- Decision
- Substantially Equivalent
- Date received
- 2013-03-11
- Decision date
- 2013-10-16
- Days to decision
- 219 days
- Clearance type
- Abbreviated
- Product code
- LBE
- Device class
- 1
- Regulation number
- 890.3850
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Santa Fe Springs, CA, US
- Third-party review
- No
- Expedited review
- No
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| CARRIER (K840250) | Convaid Products, Inc. | 1984-02-09 |
| MECHANICAL CHAIR (K820591) | Kaye Products, Inc. | 1982-03-15 |
| CONVAID CRUISER CP4M (K810676) | Convaid Products, Inc. | 1981-03-26 |
| STROLLER, THERAPY (K781947) | Convaid Products, Inc. | 1978-12-04 |
Recalls involving this device
No recalls on record reference this clearance.