K132855 is an FDA 510(k) clearance for the HEARTWAY POWER MOBILITY SCOOTER. 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 City, Taiwan, TW). The FDA issued a Cleared decision on August 29, 2014, 351 days after receiving the submission on September 12, 2013.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K132855 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 2013 |
| Decision Date | August 29, 2014 |
| Days to Decision | 351 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 |