Cleared Traditional

TYPE 4000 TRANSCUTANEOUS ELEC. STIM.

K800630 · Frye Electronics, Inc. · Neurology
Apr 1980
Decision
13d
Days
Class 2
Risk

About This 510(k) Submission

K800630 is an FDA 510(k) clearance for the TYPE 4000 TRANSCUTANEOUS ELEC. STIM., a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II — Special Controls, product code GZJ), submitted by Frye Electronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 2, 1980, 13 days after receiving the submission on March 20, 1980. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K800630 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 1980
Decision Date April 02, 1980
Days to Decision 13 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