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.
| Device ID | K112441 |
| 510k Number | K112441 |
| Device Name: | COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | DAESUNG MAREF CO., LTD. 4568 WEST 1ST STREET SUITE 104 Los Angeles, CA 90004 |
| Contact | Daniel Nam |
| Correspondent | Daniel Nam DAESUNG MAREF CO., LTD. 4568 WEST 1ST STREET SUITE 104 Los Angeles, CA 90004 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-24 |
| Decision Date | 2012-01-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18809315678985 | K112441 | 000 |
| 18809315678978 | K112441 | 000 |
| 18809315678961 | K112441 | 000 |