510(k) K884972

TRANSCOUTANEOUS ELECTRO-NEURO STIMULATOR by Futuremed Div. of Future Impex Corp. — Product Code GZJ

K884972 is an FDA 510(k) premarket notification submitted by Futuremed Div. of Future Impex Corp. for the device "TRANSCOUTANEOUS ELECTRO-NEURO STIMULATOR". The FDA issued a decision of Substantially Equivalent on July 27, 1989. 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
July 27, 1989
Date Received
November 30, 1988
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