K041677 is an FDA 510(k) clearance for the KARMA SCOOTER, MODEL KS-747.2. This device is classified as a Vehicle, Motorized 3-wheeled (Class II - Special Controls, product code INI).
Submitted by Karma Medical Products Co., Ltd. (Hsin Chu City, TW). The FDA issued a Cleared decision on August 5, 2004, 45 days after receiving the submission on June 21, 2004.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K041677 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 2004 |
| Decision Date | August 05, 2004 |
| Days to Decision | 45 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 |