The following data is part of a premarket notification filed by Won Industrial Co. with the FDA for Compressible Limb And Circulation Therapy System.
| Device ID | K120166 |
| 510k Number | K120166 |
| Device Name: | COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | WON INDUSTRIAL CO. 4568 W. 1ST, STE 104 Los Angeles, CA 90004 |
| Contact | Daniel Nam |
| Correspondent | Daniel Nam WON INDUSTRIAL CO. 4568 W. 1ST, STE 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 | 2012-01-19 |
| Decision Date | 2012-05-14 |
| Summary: | summary |