STERLING TENS— 510(k) K891118

Substantially Equivalent

Armstrong Industries, Inc.

FDA 510(k) clearance K891118 for STERLING TENS, Substantially Equivalent on 1989-09-06. Applicant: Armstrong Industries, Inc.. Device class: 2.

Clearance details

Applicant: Armstrong Industries, Inc.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1989-03-02
Decision date: 1989-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richardson, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GZJ

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 Armstrong Industries, Inc.

K970847 — IMPULSE HVG1997-09-10
K953982 — SIMPLEX TENS1997-04-25

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