The following data is part of a premarket notification filed by Merits Health Products Co., Ltd. with the FDA for Merits Model P322fwd Powered Wheelchair.
| Device ID | K122357 |
| 510k Number | K122357 |
| Device Name: | MERITS MODEL P322FWD POWERED WHEELCHAIR |
| Classification | Wheelchair, Powered |
| Applicant | MERITS HEALTH PRODUCTS CO., LTD. NO.18 JINGKE RD. NANTUN DIST Taichung, TW 40852 |
| Contact | Steve Chao |
| Correspondent | Steve Chao MERITS HEALTH PRODUCTS CO., LTD. NO.18 JINGKE RD. NANTUN DIST Taichung, TW 40852 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-03 |
| Decision Date | 2013-01-09 |
| Summary: | summary |