The following data is part of a premarket notification filed by Foshan Gaunying Electronics Co., Ltd. with the FDA for Gaunying Infrared Lamp Model Il50.
| Device ID | K101693 |
| 510k Number | K101693 |
| Device Name: | GAUNYING INFRARED LAMP MODEL IL50 |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | FOSHAN GAUNYING ELECTRONICS CO., LTD. 11820 RED HIBISCUS DRIVE Bonita Springs, FL 34135 |
| Contact | Guenter Ginsberg |
| Correspondent | Guenter Ginsberg FOSHAN GAUNYING ELECTRONICS CO., LTD. 11820 RED HIBISCUS DRIVE Bonita Springs, FL 34135 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-16 |
| Decision Date | 2011-01-05 |
| Summary: | summary |