K150987 is an FDA 510(k) clearance for the HEARTWAY Power Mobility Scooter, BRIO S19. 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, TW). The FDA issued a Cleared decision on September 22, 2015, 161 days after receiving the submission on April 14, 2015.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K150987 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 2015 |
| Decision Date | September 22, 2015 |
| Days to Decision | 161 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 |