K080134 is an FDA 510(k) clearance for the COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM, MODEL WHF-314 (POWER-Q1000). This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Wonjin Mulsan Co., Ltd. (La Mirada, US). The FDA issued a Cleared decision on January 23, 2009, 371 days after receiving the submission on January 18, 2008.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K080134 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 2008 |
| Decision Date | January 23, 2009 |
| Days to Decision | 371 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IRP - Massager, Powered Inflatable Tube |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5650 |