GZJ · Class II · 21 CFR 882.5890

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

Leading manufacturers include Wuxi Jiajian Medical Instrument Co., Ltd., Tenscare, Ltd. and Oriental Inspiration Limited.

605

Total

605

Cleared

150d

Avg days

1976

Since

Stable submission activity - 4 submissions in the last 2 years

Consistent review times: 167d avg (recent)

FDA 510(k) Cleared Stimulator, Nerve, Transcutaneous, For Pain Relief Devices (Product Code GZJ)

605 devices

1–24 of 605

1 2 3 4

CP Relief Wand Rx - TENS/NMES

Zynex Medical Officer

Physical Medicine · 117d

Cleared Apr 19, 2024

Electrical Neuromuscular Stimulator, Cure Trio

K233046

Oriental Inspiration Limited

Neurology · 207d

Cleared Jan 24, 2023

Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)

K222879

Wuxi Jiajian Medical Instrument Co., Ltd.

Neurology · 124d

1 2 3 4

About Product Code GZJ - Regulatory Context

510(k) Submission Activity

605 total 510(k) submissions under product code GZJ since 1976, with 605 receiving FDA clearance (average review time: 150 days).

Submission volume has remained relatively stable over the observed period, with 4 submissions in the last 24 months.

FDA Review Time

FDA review times for GZJ submissions have been consistent, averaging 167 days recently vs 149 days historically.

GZJ devices are reviewed by the Neurology panel. Browse all Neurology devices →