Cleared Traditional

COMFORT, MUSCLE, CORDLESS MASSAGER, BATTERY POWERED OPERATED MASSAGER

K955160 · Everapex Design & Marketing Corp. · Physical Medicine

Feb 1996

Decision

87d

Days

Class 1

Risk

About This 510(k) Submission

K955160 is an FDA 510(k) clearance for the COMFORT, MUSCLE, CORDLESS MASSAGER, BATTERY POWERED OPERATED MASSAGER, a Vibrator, Therapeutic (Class I — General Controls, product code IRO), submitted by Everapex Design & Marketing Corp. (Taipei, TW). The FDA issued a Cleared decision on February 8, 1996, 87 days after receiving the submission on November 13, 1995. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5975.

Submission Details

510(k) Number	K955160 FDA.gov
FDA Decision	Cleared SN
Date Received	November 13, 1995
Decision Date	February 08, 1996
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—