K821645 is an FDA 510(k) clearance for the BACK SKPPORTS. This device is classified as a Orthosis, Thoracic (Class I - General Controls, product code IPT).
Submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 11, 1982, 8 days after receiving the submission on June 3, 1982.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3490.
| 510(k) Number | K821645 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 1982 |
| Decision Date | June 11, 1982 |
| Days to Decision | 8 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IPT — Orthosis, Thoracic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.3490 |