The following data is part of a premarket notification filed by Motion Concepts with the FDA for Bariatric Power Positioning System (bpps).
| Device ID | K182995 |
| 510k Number | K182995 |
| Device Name: | Bariatric Power Positioning System (BPPS) |
| Classification | Wheelchair, Powered |
| 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 | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-30 |
| Decision Date | 2019-03-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00754014711475 | K182995 | 000 |
| 07540147011413 | K182995 | 000 |
| 07540147011420 | K182995 | 000 |
| 07540147011437 | K182995 | 000 |
| 07540147011468 | K182995 | 000 |
| 07540147011475 | K182995 | 000 |
| 00754014711406 | K182995 | 000 |
| 00754014711413 | K182995 | 000 |
| 00754014711420 | K182995 | 000 |
| 00754014711437 | K182995 | 000 |
| 00754014711468 | K182995 | 000 |
| 07540147011406 | K182995 | 000 |