The following data is part of a premarket notification filed by Daesung Maref Co., Ltd. with the FDA for Compressible Limb And Circulation Therapy System Model Lx7(v7).
| Device ID | K102320 |
| 510k Number | K102320 |
| Device Name: | COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL LX7(V7) |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | DAESUNG MAREF CO., LTD. 49 CANDLEWOOD WAY Buena Park, CA 90621 |
| Contact | Brandon Choi |
| Correspondent | Brandon Choi DAESUNG MAREF CO., LTD. 49 CANDLEWOOD WAY Buena Park, CA 90621 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-17 |
| Decision Date | 2011-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 48809315678139 | K102320 | 000 |
| 28809315677824 | K102320 | 000 |
| 28809315678159 | K102320 | 000 |
| 28809315678357 | K102320 | 000 |
| 28809315678364 | K102320 | 000 |
| 28809315678920 | K102320 | 000 |
| 28809315678937 | K102320 | 000 |
| 28809315678944 | K102320 | 000 |
| 38809315677906 | K102320 | 000 |
| 38809315677982 | K102320 | 000 |
| 38809315678125 | K102320 | 000 |
| 38809315678132 | K102320 | 000 |
| 48809315678122 | K102320 | 000 |
| 18809315677810 | K102320 | 000 |