The following data is part of a premarket notification filed by Ws Far Ir Medical Technology Co., Ltd. with the FDA for Ws Far Infrared Therapy Unit, Model # Ty-101 Series.
| Device ID | K080465 |
| 510k Number | K080465 |
| Device Name: | WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | WS FAR IR MEDICAL TECHNOLOGY CO., LTD. 2904 N BOLDT DRIVE Flagstaff, AZ 86001 |
| Contact | Jennifer Reich |
| Correspondent | Jennifer Reich WS FAR IR MEDICAL TECHNOLOGY CO., LTD. 2904 N BOLDT DRIVE Flagstaff, AZ 86001 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-21 |
| Decision Date | 2008-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719873220045 | K080465 | 000 |