K831033 is an FDA 510(k) clearance for the GIREX. This device is classified as a Exerciser, Non-measuring (Class I - General Controls, product code ION).
Submitted by Lancer Assoc. (Mchenry, US). The FDA issued a Cleared decision on April 27, 1983, 27 days after receiving the submission on March 31, 1983.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5370.
| 510(k) Number | K831033 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 1983 |
| Decision Date | April 27, 1983 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | ION — Exerciser, Non-measuring |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5370 |