The following data is part of a premarket notification filed by Suzhou Medical Appliance Factory with the FDA for Hwato Tdp Heat Lamp, Models Tdp11-dl, Tdp12-xl And Tdp-22xl.
| Device ID | K063568 |
| 510k Number | K063568 |
| Device Name: | HWATO TDP HEAT LAMP, MODELS TDP11-DL, TDP12-XL AND TDP-22XL |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | SUZHOU MEDICAL APPLIANCE FACTORY 1491 BAKER ST. SUITE 1 Costa Mesa, CA 92626 |
| Contact | Henry Woo |
| Correspondent | Henry Woo SUZHOU MEDICAL APPLIANCE FACTORY 1491 BAKER ST. SUITE 1 Costa Mesa, CA 92626 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-28 |
| Decision Date | 2007-03-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06901452000058 | K063568 | 000 |
| 06901452000010 | K063568 | 000 |
| 06901452000003 | K063568 | 000 |