Cleared Traditional

HEALTH ESSENTIALS FANCY PERSONAL MASSAGER

K924584 · Conair Corp. · Physical Medicine
Oct 1993
Decision
397d
Days
Class 1
Risk

About This 510(k) Submission

K924584 is an FDA 510(k) clearance for the HEALTH ESSENTIALS FANCY PERSONAL MASSAGER, a Vibrator, Therapeutic (Class I — General Controls, product code IRO), submitted by Conair Corp. (Stamford, US). The FDA issued a Cleared decision on October 12, 1993, 397 days after receiving the submission on September 10, 1992. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5975.

Submission Details

510(k) Number K924584 FDA.gov
FDA Decision Cleared SESE
Date Received September 10, 1992
Decision Date October 12, 1993
Days to Decision 397 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

Similar Devices — IRO Vibrator, Therapeutic

All 64
COMFORT, MUSCLE, CORDLESS MASSAGER, BATTERY POWERED OPERATED MASSAGER
K955160 · Everapex Design & Marketing Corp. · Feb 1996
QI GONG MASSAGER
K955250 · East Health Development Group, Inc. · Feb 1996
MASSAGER THERAPUTIC, ELECTRIC
K954203 · Cisco Sales Corp. · Dec 1995
SHIATSU MASTER MASSAGER CUSHION
K952916 · Kinsei Shiatsu, Inc. · Aug 1995
CHAMPION PHYSIOACOUSTICC RECLINER-TRANSPORTER CHAIR
K951414 · Champion Mfg. Corp. · Aug 1995
CONAIR FAMILY FITNESS BODY ENERGY
K950441 · Conair Corp. · Jul 1995