The following data is part of a premarket notification filed by Merits Health Products., Inc. with the FDA for Travel Ease Electric Scooter, Model Pioneer 3.
| Device ID | K011751 |
| 510k Number | K011751 |
| Device Name: | TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 3 |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | MERITS HEALTH PRODUCTS., INC. P.O. BOX 150356 Cape Coral, FL 33915 |
| Contact | Winston Anderson |
| Correspondent | Winston Anderson MERITS HEALTH PRODUCTS., INC. 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 | 2001-06-06 |
| Decision Date | 2001-08-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04714379291940 | K011751 | 000 |
| 04714379297515 | K011751 | 000 |
| 04714379297485 | K011751 | 000 |
| 04714379297492 | K011751 | 000 |
| 04714379291094 | K011751 | 000 |
| 04714379291100 | K011751 | 000 |
| 04714379291179 | K011751 | 000 |
| 04714379291711 | K011751 | 000 |
| 04714379291728 | K011751 | 000 |
| 04714379291735 | K011751 | 000 |
| 04714379291810 | K011751 | 000 |
| 04714379291827 | K011751 | 000 |
| 04714379297690 | K011751 | 000 |