The following data is part of a premarket notification filed by Wonjin Mulsan Co., Ltd. with the FDA for Compressible Limb Therapy System Model Whf-324 (power-q1000 Plus).
| Device ID | K100656 |
| 510k Number | K100656 |
| Device Name: | COMPRESSIBLE LIMB THERAPY SYSTEM MODEL WHF-324 (POWER-Q1000 PLUS) |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | WONJIN MULSAN CO., LTD. 49 CANDLEWOOD WAY Buena Park, CA 90621 |
| Contact | Brandon Choi |
| Correspondent | Brandon Choi WONJIN MULSAN CO., LTD. 49 CANDLEWOOD WAY Buena Park, CA 90621 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-08 |
| Decision Date | 2010-05-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809277420885 | K100656 | 000 |
| 18809277423470 | K100656 | 000 |