The following data is part of a premarket notification filed by Everlife Medical Equipment Co., Ltd. with the FDA for Everlife Interferential Current Therapy, Model If-100507.
Device ID | K070890 |
510k Number | K070890 |
Device Name: | EVERLIFE INTERFERENTIAL CURRENT THERAPY, MODEL IF-100507 |
Classification | Interferential Current Therapy |
Applicant | EVERLIFE MEDICAL EQUIPMENT CO., LTD. NO. 58, FU-CHIUN STREET Hsin Chu City, TW 30067 |
Contact | Ke-min Jen |
Correspondent | Ke-min Jen EVERLIFE MEDICAL EQUIPMENT CO., LTD. NO. 58, FU-CHIUN STREET Hsin Chu City, TW 30067 |
Product Code | LIH |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-03-30 |
Decision Date | 2007-06-29 |
Summary: | summary |