Cleared Traditional

SYNAPS (TM)

K903828 · Henley Intl. · Neurology
Jan 1991
Decision
150d
Days
Class 2
Risk

About This 510(k) Submission

K903828 is an FDA 510(k) clearance for the SYNAPS (TM), a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II — Special Controls, product code GZJ), submitted by Henley Intl. (Sugar Land, US). The FDA issued a Cleared decision on January 18, 1991, 150 days after receiving the submission on August 21, 1990. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K903828 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 1990
Decision Date January 18, 1991
Days to Decision 150 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary —

Device Classification

Product Code GZJ — Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5890

Similar Devices — GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

All 604
actiTENS mini
K252767 · Sublimed · Jan 2026
CP Relief Wand Rx - TENS/NMES
K252236 · N & C Holdings, LLC · Aug 2025
Unipro (K-UNIPRO-US)
K232441 · Tenscare, Ltd. · Aug 2024
TENSWave
K241228 · Zynex Medical Officer · Aug 2024
Electrical Neuromuscular Stimulator, Cure Trio
K233046 · Oriental Inspiration Limited · Apr 2024
Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)
K222879 · Wuxi Jiajian Medical Instrument Co., Ltd. · Jan 2023