The following data is part of a premarket notification filed by Motion Concepts with the FDA for Modular Power Standing System.
| Device ID | K191376 |
| 510k Number | K191376 |
| Device Name: | Modular Power Standing System |
| Classification | Wheelchair, Standup |
| Applicant | Motion Concepts 84 Citation Drive, Unit #1 Concord, CA L4k 3c1 |
| Contact | Dona Bhamra |
| Correspondent | Dona Bhamra Motion Concepts 84 Citation Drive, Unit #1 Concord, CA L4k 3c1 |
| Product Code | IPL |
| CFR Regulation Number | 890.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-23 |
| Decision Date | 2019-08-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00754014711451 | K191376 | 000 |
| 00754014711444 | K191376 | 000 |
| 07540147011451 | K191376 | 000 |
| 07540147011444 | K191376 | 000 |