TYPE 4000 TRANSCUTANEOUS ELEC. STIM.— 510(k) K800630

Name: FDA 510(k) clearance K800630
Creator: U.S. Food and Drug Administration
Published: 1980-04-02

Substantially Equivalent

Frye Electronics, Inc.

FDA 510(k) clearance K800630 for TYPE 4000 TRANSCUTANEOUS ELEC. STIM., Substantially Equivalent on 1980-04-02. Applicant: Frye Electronics, Inc.. Device class: 2.

Clearance details

Applicant: Frye Electronics, Inc.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1980-03-20
Decision date: 1980-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GZJ

view all

K252712 — STIMPOD NMS460 Nerve Stimulator2026-05-28
K252767 — actiTENS mini2026-01-16
K252236 — CP Relief Wand Rx - TENS/NMES2025-08-15
K232441 — Unipro (K-UNIPRO-US)2024-08-30
K241228 — TENSWave2024-08-27

More clearances from Frye Electronics, Inc.

view all

K123701 — HEARLAB ACA2013-04-05
K093006 — FONIX ,MODEL 80002009-12-30
K022510 — FONIX, MODEL 70002002-08-27
K980377 — FONIX FP35 HEARING AID ANALYZER1998-03-18
K935400 — FONIX 3500 HEARING AID ANALYZER1994-01-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.