K130644 is an FDA 510(k) clearance for the PEDIATRIC FOLDING WHEELCHAIR. This device is classified as a Stroller, Adaptive (Class I - General Controls, product code LBE).
Submitted by Columbia Medical Mfg, LLC (Santa Fe Springs, US). The FDA issued a Cleared decision on October 16, 2013, 219 days after receiving the submission on March 11, 2013.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3850.
| 510(k) Number | K130644 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 11, 2013 |
| Decision Date | October 16, 2013 |
| Days to Decision | 219 days |
| Submission Type | Abbreviated |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | LBE — Stroller, Adaptive |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.3850 |