510(k) K033857

T-TECH DIGITAL, MODEL WL-22XXA SERIES by Well-Life Healthcare, Inc. — Product Code GZJ

K033857 is an FDA 510(k) premarket notification submitted by Well-Life Healthcare, Inc. for the device "T-TECH DIGITAL, MODEL WL-22XXA SERIES". The FDA issued a decision of Substantially Equivalent on December 19, 2003. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Well-Life Healthcare, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2003
Date Received
December 11, 2003
Clearance Type
Special
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