The following data is part of a premarket notification filed by Foshan Gaunying Electronics Co., Ltd. with the FDA for Gaunying Infrared Lamp.
| Device ID | K102149 |
| 510k Number | K102149 |
| Device Name: | GAUNYING INFRARED LAMP |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | FOSHAN GAUNYING ELECTRONICS CO., LTD. HI-TECH INDUSTRIAL DEVELOPMENT Foshan, Guangdong, CN 52800 |
| Contact | Ladi Lee |
| Correspondent | William Sammons INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-07-30 |
| Decision Date | 2010-08-13 |
| Summary: | summary |