510(k) K903017

MEGA-TENS DUAL CHANNEL T.E.N.S. by Futuremed Div. of Future Impex Corp. — Product Code GZJ

K903017 is an FDA 510(k) premarket notification submitted by Futuremed Div. of Future Impex Corp. for the device "MEGA-TENS DUAL CHANNEL T.E.N.S.". The FDA issued a decision of Substantially Equivalent on October 26, 1990. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Futuremed Div. of Future Impex Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 1990
Date Received
July 10, 1990
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