The following data is part of a premarket notification filed by Merits Health Products Co., Ltd. with the FDA for Travel Ease Electric Scooter, Model: Pioneer.
| Device ID | K952042 |
| 510k Number | K952042 |
| Device Name: | TRAVEL EASE ELECTRIC SCOOTER, MODEL: PIONEER |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | MERITS HEALTH PRODUCTS CO., LTD. 505 NORTH DEL PRADO Cape Copral, FL 33909 |
| Contact | Nancy Anderson |
| Correspondent | Nancy Anderson MERITS HEALTH PRODUCTS CO., LTD. 505 NORTH DEL PRADO Cape Copral, FL 33909 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-01 |
| Decision Date | 1996-03-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04714379291148 | K952042 | 000 |
| 04714379291131 | K952042 | 000 |