The following data is part of a premarket notification filed by Harbin Quanke Medi-technical Development Co., Ltd. with the FDA for Qk-systemic Therapeutic Apparatus.
| Device ID | K141892 |
| 510k Number | K141892 |
| Device Name: | QK-SYSTEMIC THERAPEUTIC APPARATUS |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | HARBIN QUANKE MEDI-TECHNICAL DEVELOPMENT CO., LTD. NO 42-1 LANE 2, JIN WEI STR. DAOLI DIST. Harbin, Heilongjiang, CN 150010 |
| Contact | Wang Xianglin |
| Correspondent | Wang Xianglin HARBIN QUANKE MEDI-TECHNICAL DEVELOPMENT CO., LTD. NO 42-1 LANE 2, JIN WEI STR. DAOLI DIST. Harbin, Heilongjiang, CN 150010 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-14 |
| Decision Date | 2015-01-28 |
| Summary: | summary |