Cleared Traditional

SONASSAGE

K923238 · Conair Corp. · Physical Medicine
Feb 1994
Decision
580d
Days
Class 1
Risk

About This 510(k) Submission

K923238 is an FDA 510(k) clearance for the SONASSAGE, a Vibrator, Therapeutic (Class I — General Controls, product code IRO), submitted by Conair Corp. (Stamford, US). The FDA issued a Cleared decision on February 2, 1994, 580 days after receiving the submission on July 2, 1992. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5975.

Submission Details

510(k) Number K923238 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 1992
Decision Date February 02, 1994
Days to Decision 580 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

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

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