K072104 is an FDA 510(k) clearance for the HEARTWAY POWER MOBILITY SCOOTER, PF6. This device is classified as a Vehicle, Motorized 3-wheeled (Class II - Special Controls, product code INI).
Submitted by Heartway Medical Products Co., Ltd. (Taichung, TW). The FDA issued a Cleared decision on August 17, 2007, 17 days after receiving the submission on July 31, 2007.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K072104 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 2007 |
| Decision Date | August 17, 2007 |
| Days to Decision | 17 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 |