Cleared Traditional

EMS 8100

K895301 · Henley Intl. · Physical Medicine
Feb 1990
Decision
179d
Days
Class 2
Risk

About This 510(k) Submission

K895301 is an FDA 510(k) clearance for the EMS 8100, a Stimulator, Muscle, Powered (Class II — Special Controls, product code IPF), submitted by Henley Intl. (Sugar Land, US). The FDA issued a Cleared decision on February 20, 1990, 179 days after receiving the submission on August 25, 1989. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number K895301 FDA.gov
FDA Decision Cleared SESE
Date Received August 25, 1989
Decision Date February 20, 1990
Days to Decision 179 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code IPF — Stimulator, Muscle, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5850