K802442 is an FDA 510(k) clearance for the LOW BACK 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 October 31, 1980, 24 days after receiving the submission on October 7, 1980.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3490.
| 510(k) Number | K802442 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 1980 |
| Decision Date | October 31, 1980 |
| Days to Decision | 24 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 |