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
241–264 of 606
Cleared Feb 26, 1997
SHE-LI TENS STIMULATOR MODEL SL-101 RX
K961809
Medi Consultants, Inc.
Neurology · 292d
Cleared Feb 13, 1997
SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I STANDARD)
K963729
Skylark Device Co., Ltd.
Neurology · 150d
Cleared Feb 06, 1997
M AND R REUSABLE ELECTRODES (MULTIPLE)
K963125
M & R Mfg., Inc.
Neurology · 178d
Cleared Oct 22, 1996
ACTION POTENTIAL SIMULATION THERAPY DEVICE
K955470
Neurotech, Inc.
Neurology · 327d
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 Dec 22, 1995
ENDURA REUSABLE TENS AND NMES ELECTRODES
K946230
Selectivemed Components, Inc.
Neurology · 365d
Cleared Oct 27, 1995
ELECTROCARE
K942631
Waco Corp.
Neurology · 511d
Cleared Sep 29, 1995
STIMULATOR, NERVE, TRANSCUTANEOUS, (PAIN RELIEF) 84-GZJ
K940600
Progressive Concepts, Inc.
Neurology · 596d
Cleared Jun 26, 1995
PGS123 AND HVS-123
K946299
Skylark Device Co., Ltd.
Neurology · 181d
Cleared Jun 02, 1995
THE SIGNATURE SERIES, M IV
K933197
Progressive Electrical Therapeutics
Neurology · 701d
Cleared Jun 02, 1995
STERILE TREATMENT ELECTRODE
K941923
Staodyne, Inc.
Neurology · 408d
Cleared May 15, 1995
TRANSAMERICAN CLASSIC TENS
K944280
Transamerica Biomedical, Inc.
Neurology · 258d
Cleared Jan 30, 1995
GUARDIAN DISPOSABLE TENS AND TENS/NMES ELECTRODES
K945676
Selectivemed Components, Inc.
Neurology · 73d
Cleared Sep 08, 1994
MEDI-STIM, MODIFICATION
K933237
Mid-Canada Medical
Neurology · 441d
Cleared Jul 11, 1994
BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD)
K934051
Skylark Device Co., Ltd.
Neurology · 326d
Cleared Jul 01, 1994
TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR
K932897
Nemectron GmbH
Neurology · 382d