The following data is part of a premarket notification filed by Merits Medical Industries Co., Ltd. with the FDA for Travel Ease Electric Scooter Model # Pioneer 2.
| Device ID | K011707 |
| 510k Number | K011707 |
| Device Name: | TRAVEL EASE ELECTRIC SCOOTER MODEL # PIONEER 2 |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | MERITS MEDICAL INDUSTRIES CO., LTD. P.O.BOX 150356 Cape Coral, FL 33915 |
| Contact | Winston Anderson |
| Correspondent | Winston Anderson MERITS MEDICAL INDUSTRIES 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 | 2001-06-04 |
| Decision Date | 2001-08-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04714379292206 | K011707 | 000 |
| 04714379291551 | K011707 | 000 |
| 04714379291223 | K011707 | 000 |
| 04714379291216 | K011707 | 000 |
| 04714379291209 | K011707 | 000 |
| 04714379291162 | K011707 | 000 |
| 04714379291155 | K011707 | 000 |
| 04714379292770 | K011707 | 000 |