K823152 is an FDA 510(k) clearance for the OB HELP ARM. This device is classified as a Sling, Arm, Overhead Supported (Class I - General Controls, product code ILE).
Submitted by Orthion Corp. (Mchenry, US). The FDA issued a Cleared decision on November 5, 1982, 16 days after receiving the submission on October 20, 1982.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3475.
| 510(k) Number | K823152 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 1982 |
| Decision Date | November 05, 1982 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | ILE — Sling, Arm, Overhead Supported |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.3475 |