The following data is part of a premarket notification filed by Daesung Maref Co., Ltd with the FDA for Lympha-flow(lf1200).
| Device ID | K160178 |
| 510k Number | K160178 |
| Device Name: | Lympha-Flow(LF1200) |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | DaeSung Maref Co., Ltd 298-24, Gongdan-ro Gunpo-si, KR 15809 |
| Contact | Jae-wha Lee |
| Correspondent | Dave Kim Mtech Group 8310 Buffalo Speedway Houston, TX 77025 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-27 |
| Decision Date | 2017-01-11 |
| Summary: | summary |