K040097 is an FDA 510(k) clearance for the MEDLINE STRIDER MIDI 3. This device is classified as a Vehicle, Motorized 3-wheeled (Class II - Special Controls, product code INI).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on February 13, 2004, 24 days after receiving the submission on January 20, 2004.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K040097 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 20, 2004 |
| Decision Date | February 13, 2004 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | INI — Vehicle, Motorized 3-wheeled |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.3800 |