COSMODYN-S INTERFERENTIAL MUSCLE STIM— 510(k) K833945

Name: FDA 510(k) clearance K833945
Creator: U.S. Food and Drug Administration
Published: 1983-12-23

Substantially Equivalent

Leo Unlimited, Inc.

FDA 510(k) clearance K833945 for COSMODYN-S INTERFERENTIAL MUSCLE STIM, Substantially Equivalent on 1983-12-23. Applicant: Leo Unlimited, Inc.. Device class: 2.

Clearance details

Applicant: Leo Unlimited, Inc.
Product code: Code IPF
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 1983-11-15
Decision date: 1983-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IPF

view all

K253542 — Apollo Quattro (APQ-10M)2026-06-08
K252816 — High Tone Power therapy (HiToP) (Model: HiToP PNP)2026-06-02
K260142 — StimelMD (SSMD) system2026-05-27
K251083 — Compact II2025-09-12
K241433 — EVE Synergy (EVE-20M)2025-06-04

More clearances from Leo Unlimited, Inc.

view all

K834572 — EPITRON SUPER1984-04-23
K833946 — EPILOT 80 S TM1984-04-04

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