The following data is part of a premarket notification filed by United Pacific Co., Ltd. with the FDA for Qk-wide Band Spectrum Therapeutic Apparatus, Models Co1a, Co1b, Co1c, Co1d, Co2a, Co2b.
| Device ID | K993123 |
| 510k Number | K993123 |
| Device Name: | QK-WIDE BAND SPECTRUM THERAPEUTIC APPARATUS, MODELS CO1A, CO1B, CO1C, CO1D, CO2A, CO2B |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | UNITED PACIFIC CO., LTD. 219 SOUTH RAYMOND AVE. Alhambra, CA 91801 |
| Contact | Daniel Ye Hua |
| Correspondent | Daniel Ye Hua UNITED PACIFIC CO., LTD. 219 SOUTH RAYMOND AVE. Alhambra, CA 91801 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-20 |
| Decision Date | 1999-12-17 |