Cleared Traditional

MARK V HIGH VOLTAGE GALVANIC STIMULATORR

K832546 · Orthion Corp. · Physical Medicine

Oct 1983

Decision

77d

Days

Class 2

Risk

About This 510(k) Submission

K832546 is an FDA 510(k) clearance for the MARK V HIGH VOLTAGE GALVANIC STIMULATORR, a Stimulator, Muscle, Powered (Class II — Special Controls, product code IPF), submitted by Orthion Corp. (Mchenry, US). The FDA issued a Cleared decision on October 14, 1983, 77 days after receiving the submission on July 29, 1983. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K832546 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 29, 1983
Decision Date	October 14, 1983
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—