510(k) K071624

EVERELIFE TRANSCUTANEOUS MUSCLE STIMULATOR by Everlife Medical Equipment Co., Ltd. — Product Code GZJ

K071624 is an FDA 510(k) premarket notification submitted by Everlife Medical Equipment Co., Ltd. for the device "EVERELIFE TRANSCUTANEOUS MUSCLE STIMULATOR". The FDA issued a decision of Substantially Equivalent on November 27, 2007. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), 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
November 27, 2007
Date Received
June 14, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type