The following data is part of a premarket notification filed by Wonjin Mulsan Co., Ltd. with the FDA for Compressible Limb And Circulation Therapy System, Model Whf-314 (power-q1000).
| Device ID | K080134 |
| 510k Number | K080134 |
| Device Name: | COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM, MODEL WHF-314 (POWER-Q1000) |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | WONJIN MULSAN CO., LTD. 155 FLEMINGTON COURT La Mirada, CA 90638 |
| Contact | Brandon Choi |
| Correspondent | Brandon Choi WONJIN MULSAN CO., LTD. 155 FLEMINGTON COURT La Mirada, CA 90638 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-18 |
| Decision Date | 2009-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 48809277426021 | K080134 | 000 |
| 08809277420014 | K080134 | 000 |