Cleared Traditional

SHIATSU MASTER MASSAGER CUSHION

K952916 · Kinsei Shiatsu, Inc. · Physical Medicine
Aug 1995
Decision
63d
Days
Class 1
Risk

About This 510(k) Submission

K952916 is an FDA 510(k) clearance for the SHIATSU MASTER MASSAGER CUSHION, a Vibrator, Therapeutic (Class I — General Controls, product code IRO), submitted by Kinsei Shiatsu, Inc. (Torrance, US). The FDA issued a Cleared decision on August 28, 1995, 63 days after receiving the submission on June 26, 1995. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5975.

Submission Details

510(k) Number K952916 FDA.gov
FDA Decision Cleared SN
Date Received June 26, 1995
Decision Date August 28, 1995
Days to Decision 63 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

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
CHAMPION PHYSIOACOUSTICC RECLINER-TRANSPORTER CHAIR
K951414 · Champion Mfg. Corp. · Aug 1995
CONAIR FAMILY FITNESS BODY ENERGY
K950441 · Conair Corp. · Jul 1995
SKALPI 3200
K946382 · Wiscco Development, Inc. · May 1995