Cleared Traditional

MASSAGER THERAPUTIC, ELECTRIC

K954203 · Cisco Sales Corp. · Physical Medicine

Dec 1995

Decision

95d

Days

Class 1

Risk

About This 510(k) Submission

K954203 is an FDA 510(k) clearance for the MASSAGER THERAPUTIC, ELECTRIC, a Vibrator, Therapeutic (Class I — General Controls, product code IRO), submitted by Cisco Sales Corp. (Torrance, US). The FDA issued a Cleared decision on December 11, 1995, 95 days after receiving the submission on September 7, 1995. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5975.

Submission Details

510(k) Number	K954203 FDA.gov
FDA Decision	Cleared SN
Date Received	September 07, 1995
Decision Date	December 11, 1995
Days to Decision	95 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—