K952042 is an FDA 510(k) clearance for the TRAVEL EASE ELECTRIC SCOOTER, MODEL: PIONEER. 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 Copral, US). The FDA issued a Cleared decision on March 4, 1996, 308 days after receiving the submission on May 1, 1995.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K952042 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 1995 |
| Decision Date | March 04, 1996 |
| Days to Decision | 308 days |
| Submission Type | Traditional |
| 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 |