Cleared Traditional

SKALPI 3200

K946382 · Wiscco Development, Inc. · Physical Medicine

May 1995

Decision

167d

Days

Class 1

Risk

About This 510(k) Submission

K946382 is an FDA 510(k) clearance for the SKALPI 3200, a Vibrator, Therapeutic (Class I — General Controls, product code IRO), submitted by Wiscco Development, Inc. (North Hollywood, US). The FDA issued a Cleared decision on May 30, 1995, 167 days after receiving the submission on December 14, 1994. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5975.

Submission Details

510(k) Number	K946382 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 14, 1994
Decision Date	May 30, 1995
Days to Decision	167 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement