K042763 is an FDA 510(k) clearance for the MODIFICATION TO 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 October 7, 2004, 2 days after receiving the submission on October 5, 2004.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K042763 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 05, 2004 |
| Decision Date | October 07, 2004 |
| Days to Decision | 2 days |
| Submission Type | Special |
| 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 |