The following data is part of a premarket notification filed by Won Industrial Co. with the FDA for Compressible Limb And Circulation Therapy System Model Wic-2008.
| Device ID | K102319 |
| 510k Number | K102319 |
| Device Name: | COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL WIC-2008 |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | WON INDUSTRIAL CO. 49 CANDLEWOOD WAY Buena Park, CA 90621 |
| Contact | Brandon Choi |
| Correspondent | Brandon Choi WON INDUSTRIAL CO. 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 | 2011-01-28 |
| Summary: | summary |