GZJ · Class II · 21 CFR 882.5890

FDA Product Code GZJ: Stimulator, Nerve, Transcutaneous, For Pain Relief

Leading manufacturers include Biomedical Life Systems, Inc., Empi and Medical Devices, Inc..

606
Total
606
Cleared
150d
Avg days
1976
Since
606 devices
145–168 of 606
Cleared Sep 12, 1996
SMART-TENS, MODEL 456
K961376
Bio-Medical Research, Ltd.
Neurology · 157d
Cleared Sep 05, 1996
SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECTRODE - MODIFY
K962910
Uni-Patch, Inc.
Neurology · 62d
Cleared Jul 31, 1996
TENS/FES/NMES ELECTRODES
K962332
Uni-Patch, Inc.
Neurology · 44d
Cleared Jun 21, 1996
TRANSAMERICA ELECTRODE
K961749
Transamerica Medical Systems
Neurology · 88d
Cleared May 30, 1996
TAYLOR GENERAL PURPOSE MONITORING ELECTRODE
K954951
Taylor Industries, Inc.
Neurology · 213d
Cleared May 17, 1996
FOCUS MODEL 795 UNIT
K951951
Empi
Neurology · 387d
Cleared May 15, 1996
GALVA 5-T
K960969
Zimmer Elektromedizin GmbH
Neurology · 65d
Cleared Mar 20, 1996
EPIX XL TENS UNIT
K951903
Empi
Neurology · 331d
Cleared Jan 22, 1996
ACUPLUS
K954334
S.H.P. Intl. Pty., Ltd.
Neurology · 126d
Cleared Jun 26, 1995
PGS123 AND HVS-123
K946299
Skylark Device Co., Ltd.
Neurology · 181d
Cleared Jul 11, 1994
BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD)
K934051
Skylark Device Co., Ltd.
Neurology · 326d
Cleared Jun 09, 1994
STAT-TENS
K931079
Skylark Device Co., Ltd.
Neurology · 463d
Cleared May 26, 1994
THERAPEUTIC ULTRASOUND AND STIMULATOR
K935324
Chattanooga Group, Inc.
Neurology · 202d
Cleared Mar 14, 1994
HOME MICROCURRENT HMC
K935132
Medical Devices, Inc.
Neurology · 137d
Cleared Feb 23, 1994
FLEXMATE
K934619
Medical Devices, Inc.
Neurology · 149d
Cleared May 17, 1993
K-STIM CLEAR
K922202
Katecho, Inc.
Neurology · 371d
Cleared Mar 18, 1993
THERA PULSE A ELECTRO NERVE STIMULATOR
K925686
Biomedical Life Systems, Inc.
Neurology · 126d
Cleared Jan 22, 1993
SD-602 SD MODE 11, SD-603 SD MOD 111
K925729
Skylark Device Co., Ltd.
Neurology · 70d
Cleared Oct 23, 1992
TX-3 SD
K923934
Skylark Device Co., Ltd.
Neurology · 79d
Cleared Oct 15, 1992
SD-605 SD II PROGRAM
K923935
Skylark Device Co., Ltd.
Neurology · 71d
Cleared Oct 13, 1992
INTELECT 600MP
K920260
Chattanooga Group, Inc.
Neurology · 266d
Cleared Oct 13, 1992
MICRO 100,200,300, & 400 TENS
K923298
Skylark Device Co., Ltd.
Neurology · 99d
Cleared Oct 06, 1992
K-DISPERSE
K921679
Katecho, Inc.
Neurology · 181d
Cleared Sep 22, 1992
TEAM-MC II
K921828
Henley Intl.
Neurology · 159d