The following data is part of a premarket notification filed by Ws Far Ir Medical Technology Co., Ltd. with the FDA for Ws(tm) Far-infrared Therapy Unit, Model Kp-b210.
| Device ID | K160849 |
| 510k Number | K160849 |
| Device Name: | WS(TM) Far-Infrared Therapy Unit, Model KP-B210 |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | WS FAR IR MEDICAL TECHNOLOGY CO., LTD. 2F, NO.4, LANE 130, MINQUAN RD. XINDIAN DIST. New Taipei City, TW 231 |
| Contact | Chih-wen Tsai |
| Correspondent | Chih-wen Tsai WS FAR IR MEDICAL TECHNOLOGY CO., LTD. 2F, NO.4, LANE 130, MINQUAN RD. XINDIAN DIST. New Taipei City, TW 231 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-28 |
| Decision Date | 2016-12-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719873220199 | K160849 | 000 |