K821837 is an FDA 510(k) clearance for the VARI-SUPPORT NECK POSTURE PILLOW. This device is classified as a Orthosis, Cervical (Class I - General Controls, product code IQK).
Submitted by Body Therapeutics, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 20, 1982, 28 days after receiving the submission on June 22, 1982.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3490.
| 510(k) Number | K821837 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 22, 1982 |
| Decision Date | July 20, 1982 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IQK — Orthosis, Cervical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.3490 |