K001937 is an FDA 510(k) clearance for the MEDLINE ELECTRONIC POSITIONING CHAIR. This device is classified as a Chair, Positioning, Electric (Class II - Special Controls, product code INO).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on September 22, 2000, 88 days after receiving the submission on June 26, 2000.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3110.
| 510(k) Number | K001937 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 2000 |
| Decision Date | September 22, 2000 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | INO — Chair, Positioning, Electric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.3110 |