The following data is part of a premarket notification filed by Merits Health Products., Inc. with the FDA for Merits Wheelchair.
| Device ID | K933662 |
| 510k Number | K933662 |
| Device Name: | MERITS WHEELCHAIR |
| Classification | Wheelchair, Powered |
| Applicant | MERITS HEALTH PRODUCTS., INC. 505 N. DEL PRADO BLVD. Cape Coral, FL 33909 |
| Contact | Nancy Anderson |
| Correspondent | Nancy Anderson MERITS HEALTH PRODUCTS., INC. 505 N. DEL PRADO BLVD. Cape Coral, FL 33909 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-27 |
| Decision Date | 1994-03-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04714379290790 | K933662 | 000 |
| 04714379290783 | K933662 | 000 |
| 04714379290776 | K933662 | 000 |
| 04714379290769 | K933662 | 000 |
| 04714379290752 | K933662 | 000 |
| 04714379290738 | K933662 | 000 |
| 04714379290721 | K933662 | 000 |
| 04714379290714 | K933662 | 000 |