The following data is part of a premarket notification filed by Columbia Medical Mfg, Llc with the FDA for Pediatric Folding Wheelchair.
| Device ID | K130644 |
| 510k Number | K130644 |
| Device Name: | PEDIATRIC FOLDING WHEELCHAIR |
| Classification | Stroller, Adaptive |
| Applicant | COLUMBIA MEDICAL MFG, LLC 11724 WILLAKE ST Santa Fe Springs, CA 90670 |
| Contact | Gary Werschmidt |
| Correspondent | Gary Werschmidt COLUMBIA MEDICAL MFG, LLC 11724 WILLAKE ST Santa Fe Springs, CA 90670 |
| Product Code | LBE |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-11 |
| Decision Date | 2013-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00822383001517 | K130644 | 000 |
| 00822383987668 | K130644 | 000 |
| 00822383987651 | K130644 | 000 |
| 00822383987644 | K130644 | 000 |
| 00822383987637 | K130644 | 000 |
| 00822383986722 | K130644 | 000 |
| 00822383986692 | K130644 | 000 |