The following data is part of a premarket notification filed by Merits Health Products., Inc. with the FDA for Mp3u, Power Wheelchair.
| Device ID | K011513 |
| 510k Number | K011513 |
| Device Name: | MP3U, POWER WHEELCHAIR |
| Classification | Wheelchair, Powered |
| Applicant | MERITS HEALTH PRODUCTS., INC. P.O. BOX 150356 Cape Coral, FL 33915 |
| Contact | Winston Anderson |
| Correspondent | Winston Anderson MERITS HEALTH PRODUCTS., INC. P.O. BOX 150356 Cape Coral, FL 33915 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-16 |
| Decision Date | 2001-08-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04714379292442 | K011513 | 000 |
| 04714379292435 | K011513 | 000 |
| 04714379292251 | K011513 | 000 |
| 04714379292244 | K011513 | 000 |
| 04714379290882 | K011513 | 000 |
| 04714379290875 | K011513 | 000 |
| 04714379294538 | K011513 | 000 |