Cleared Traditional

EMS/400

K913272 · Altoona Medical Supply · Physical Medicine
Aug 1991
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K913272 is an FDA 510(k) clearance for the EMS/400, a Stimulator, Muscle, Powered (Class II — Special Controls, product code IPF), submitted by Altoona Medical Supply (Altoona, US). The FDA issued a Cleared decision on August 22, 1991, 30 days after receiving the submission on July 23, 1991. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number K913272 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 1991
Decision Date August 22, 1991
Days to Decision 30 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

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