Cleared Traditional

SQUEEZE PLAY

K943730 · Conair Corp. · Physical Medicine
Nov 1994
Decision
118d
Days
Class 1
Risk

About This 510(k) Submission

K943730 is an FDA 510(k) clearance for the SQUEEZE PLAY, a Vibrator, Therapeutic (Class I — General Controls, product code IRO), submitted by Conair Corp. (Stamford, US). The FDA issued a Cleared decision on November 28, 1994, 118 days after receiving the submission on August 2, 1994. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5975.

Submission Details

510(k) Number K943730 FDA.gov
FDA Decision Cleared SN
Date Received August 02, 1994
Decision Date November 28, 1994
Days to Decision 118 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code IRO — Vibrator, Therapeutic
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5975

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