SCHULDT* PC* - DUAL CHANNEL TENS— 510(k) K880980

Name: FDA 510(k) clearance K880980
Creator: U.S. Food and Drug Administration
Published: 1988-04-11

Substantially Equivalent

Schuldt Laboratories, Inc.

FDA 510(k) clearance K880980 for SCHULDT* PC* - DUAL CHANNEL TENS, Substantially Equivalent on 1988-04-11. Applicant: Schuldt Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Schuldt Laboratories, Inc.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1988-03-08
Decision date: 1988-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada, CA

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 Schuldt Laboratories, Inc.

view all

K864368 — SCHULDT* PLUS 8 T.E.N.S. DEVICE1987-02-26

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