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 |