K032446 is an FDA 510(k) clearance for the MEDLINE STRIDER, MODELS MIDI 3 AND MIDI 4. 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 12, 2004, 188 days after receiving the submission on August 8, 2003.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K032446 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 08, 2003 |
| Decision Date | February 12, 2004 |
| Days to Decision | 188 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 |