FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

TRANSCUTANEOUS NERVE STIMULATOR FOR PAIN RELIEF

K Number: K850004 · Decision Apr 2, 1985
Classifications
1
FEI Numbers
179
Registration Numbers
179
Same Product Code
601
Applicant Total
6
Review Days
90

Basic Information

Device Name
TRANSCUTANEOUS NERVE STIMULATOR FOR PAIN RELIEF
K Number
K850004
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
882.5890
Medical Specialty
Neurology
Decision
Substantially Equivalent
Applicant
TODD MEDICAL, INC.
Date Received
January 2, 1985
Decision Date
April 2, 1985
Product Code
GZJ
Advisory Committee
Neurology
Review Advisory Committee
NE
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

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