K070493 is an FDA 510(k) clearance for the HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, P17RT. 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 March 23, 2007, 31 days after receiving the submission on February 20, 2007.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K070493 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 20, 2007 |
| Decision Date | March 23, 2007 |
| Days to Decision | 31 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 |