The following data is part of a premarket notification filed by Merits Health Products Co., Ltd. with the FDA for Merits Transformer Power Scooter, S941.
| Device ID | K142162 |
| 510k Number | K142162 |
| Device Name: | MERITS TRANSFORMER POWER SCOOTER, S941 |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | MERITS HEALTH PRODUCTS CO., LTD. NO.18 JINGKE RD. NANTUN DIST Taichung, TW 40852 |
| Contact | Vincent Chen |
| Correspondent | Vincent Chen MERITS HEALTH PRODUCTS CO., LTD. NO.18 JINGKE RD. NANTUN DIST Taichung, TW 40852 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-06 |
| Decision Date | 2015-05-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04714379291247 | K142162 | 000 |
| 04714379291230 | K142162 | 000 |