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 5.
| Device ID | K013788 |
| 510k Number | K013788 |
| Device Name: | TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 5 |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | MERITS HEALTH PRODUCTS CO., LTD. P.O. BOX 150356 Cape Coral, FL 33915 |
| Contact | Winston Anderson |
| Correspondent | Winston Anderson MERITS HEALTH PRODUCTS CO., LTD. P.O. BOX 150356 Cape Coral, FL 33915 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-14 |
| Decision Date | 2001-12-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04714379292190 | K013788 | 000 |
| 04714379291995 | K013788 | 000 |
| 04714379291544 | K013788 | 000 |
| 04714379291537 | K013788 | 000 |
| 04714379291193 | K013788 | 000 |
| 04714379292763 | K013788 | 000 |
| 04714379294507 | K013788 | 000 |
| 04714379294491 | K013788 | 000 |