510(k) K070890

EVERLIFE INTERFERENTIAL CURRENT THERAPY, MODEL IF-100507 by Everlife Medical Equipment Co., Ltd. — Product Code LIH

K070890 is an FDA 510(k) premarket notification submitted by Everlife Medical Equipment Co., Ltd. for the device "EVERLIFE INTERFERENTIAL CURRENT THERAPY, MODEL IF-100507". The FDA issued a decision of Substantially Equivalent on June 29, 2007. The device falls under product code LIH (Interferential Current Therapy), a Class II device regulated under 21 CFR 882.5890. Everlife Medical Equipment Co., Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2007
Date Received
March 30, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Interferential Current Therapy
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type