The following data is part of a premarket notification filed by Merits Health Products Co., Ltd. with the FDA for Merits P335 Powered Wheelchair.
| Device ID | K220529 |
| 510k Number | K220529 |
| Device Name: | Merits P335 Powered Wheelchair |
| Classification | Wheelchair, Powered |
| Applicant | Merits Health Products Co., LTD. No. 18, Jingke Rd., Nantun Dist. Taichung, TW 40852 |
| Contact | Martin Tseng |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2022-02-24 |
| Decision Date | 2022-03-18 |