The following data is part of a premarket notification filed by Chung Cheng Electric Heating Co., Ltd. with the FDA for Chung Cheng Far Infrared Ray Healthful Lamp (or Medical Fir Radiator), Model Ch-8810.
| Device ID | K053376 |
| 510k Number | K053376 |
| Device Name: | CHUNG CHENG FAR INFRARED RAY HEALTHFUL LAMP (OR MEDICAL FIR RADIATOR), MODEL CH-8810 |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | CHUNG CHENG ELECTRIC HEATING CO., LTD. 2904 N. BOLDT DRIVE Flagstaff, AZ 86001 |
| Contact | Jennifer Reich |
| Correspondent | Jennifer Reich CHUNG CHENG ELECTRIC HEATING 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 | 2005-12-05 |
| Decision Date | 2006-02-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04716171749018 | K053376 | 000 |