K071007 is an FDA 510(k) clearance for the HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S33. This device is classified as a Vehicle, Motorized 3-wheeled (Class II - Special Controls, product code INI).
Submitted by Heartway Medical Products Co., Ltd. (Hsin-Chu City, TW). The FDA issued a Cleared decision on April 19, 2007, 10 days after receiving the submission on April 9, 2007.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K071007 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 09, 2007 |
| Decision Date | April 19, 2007 |
| Days to Decision | 10 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | INI — Vehicle, Motorized 3-wheeled |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.3800 |