K813632 is an FDA 510(k) clearance for the COLOR CODED WEIGHT CUFFS. This device is classified as a Components, Exercise (Class I - General Controls, product code IOD).
Submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 19, 1982, 21 days after receiving the submission on December 29, 1981.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5350.
| 510(k) Number | K813632 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 1981 |
| Decision Date | January 19, 1982 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IOD — Components, Exercise |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5350 |