The following data is part of a premarket notification filed by Shenzhen Anpan Technology Co., Ltd. with the FDA for Fir Heat Theraphy Sysyems.
| Device ID | K111273 |
| 510k Number | K111273 |
| Device Name: | FIR HEAT THERAPHY SYSYEMS |
| Classification | Pad, Heating, Powered |
| Applicant | SHENZHEN ANPAN TECHNOLOGY CO., LTD. #44, 2ND ROAD, XIAKENG, TONGLE COMMUNITY, LONG GANG TOWN Shenzhen, CN 518116 |
| Contact | Wang Tao |
| Correspondent | Wang Tao SHENZHEN ANPAN TECHNOLOGY CO., LTD. #44, 2ND ROAD, XIAKENG, TONGLE COMMUNITY, LONG GANG TOWN Shenzhen, CN 518116 |
| Product Code | IRT |
| CFR Regulation Number | 890.5740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-04 |
| Decision Date | 2011-11-08 |
| Summary: | summary |