The following data is part of a premarket notification filed by Choyang Medical Instrument Co., Ltd. with the FDA for Choyang Thermal Massager.
| Device ID | K111941 |
| 510k Number | K111941 |
| Device Name: | CHOYANG THERMAL MASSAGER |
| Classification | Table, Physical Therapy, Multi Function |
| Applicant | CHOYANG MEDICAL INSTRUMENT CO., LTD. 8 EAST BROADWAY SUITE 611 Salt Lake City, UT 84111 |
| Contact | Shin Kuk Yoo |
| Correspondent | Shin Kuk Yoo CHOYANG MEDICAL INSTRUMENT CO., LTD. 8 EAST BROADWAY SUITE 611 Salt Lake City, UT 84111 |
| Product Code | JFB |
| CFR Regulation Number | 890.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-08 |
| Decision Date | 2012-05-25 |
| Summary: | summary |