K870125 is an FDA 510(k) clearance for the EXTREMITY ELEVATOR. This device is classified as a Apparatus, Traction, Non-powered (Class I - General Controls, product code HST).
Submitted by Orthopedic Systems, Inc. (Hayward, US). The FDA issued a Cleared decision on February 4, 1987, 23 days after receiving the submission on January 12, 1987.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 888.5850.
| 510(k) Number | K870125 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 12, 1987 |
| Decision Date | February 04, 1987 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | HST — Apparatus, Traction, Non-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.5850 |