K073044 is an FDA 510(k) clearance for the HEARTWAY POWER MOBILITY SCOOTER, MODEL PT7. 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 December 7, 2007, 39 days after receiving the submission on October 29, 2007.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K073044 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 29, 2007 |
| Decision Date | December 07, 2007 |
| Days to Decision | 39 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 |