K013788 is an FDA 510(k) clearance for the TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 5. This device is classified as a Vehicle, Motorized 3-wheeled (Class II - Special Controls, product code INI).
Submitted by Merits Health Products Co., Ltd. (Cape Coral, US). The FDA issued a Cleared decision on December 11, 2001, 27 days after receiving the submission on November 14, 2001.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K013788 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 2001 |
| Decision Date | December 11, 2001 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | INI - Vehicle, Motorized 3-wheeled |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.3800 |