K150033 is an FDA 510(k) clearance for the Air Compressible Limb Therapy System. This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Daesung Maref Co., Ltd. (Gunpo-Shi, KR). The FDA issued a Cleared decision on April 20, 2015, 101 days after receiving the submission on January 9, 2015.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K150033 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 2015 |
| Decision Date | April 20, 2015 |
| Days to Decision | 101 days |
| Submission Type | Special |
| 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 |