K160178 is an FDA 510(k) clearance for the Lympha-Flow(LF1200). This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Daesung Maref Co., Ltd. (Gunpo-Si, KR). The FDA issued a Cleared decision on January 11, 2017, 350 days after receiving the submission on January 27, 2016.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K160178 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 27, 2016 |
| Decision Date | January 11, 2017 |
| Days to Decision | 350 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 |