K040818 is an FDA 510(k) clearance for the MEDLINE STRIDER MINI 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 May 7, 2004, 38 days after receiving the submission on March 30, 2004.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K040818 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 30, 2004 |
| Decision Date | May 07, 2004 |
| Days to Decision | 38 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 |