The following data is part of a premarket notification filed by Wonjinmulsan Co., Ltd. with the FDA for Compressible Limb Therapy System.
| Device ID | K113275 |
| 510k Number | K113275 |
| Device Name: | COMPRESSIBLE LIMB THERAPY SYSTEM |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | WONJINMULSAN CO., LTD. D-524 MIGUN TECHNO WORLD 2 533-1 YONGSAN-DONGYUSEONG-GU Daejeon, KR Ks |
| Contact | Eileen Yang |
| Correspondent | Eileen Yang WONJINMULSAN CO., LTD. D-524 MIGUN TECHNO WORLD 2 533-1 YONGSAN-DONGYUSEONG-GU Daejeon, KR Ks |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-04 |
| Decision Date | 2012-02-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38809277420442 | K113275 | 000 |
| 38809277423214 | K113275 | 000 |
| 18809277421674 | K113275 | 000 |