Cleared Traditional

K943092 - FAMILY FITNESS SHIATSU MASSAGER

K943092 is the FDA 510(k) clearance for FAMILY FITNESS SHIATSU MASSAGER by Conair Corp.. It is a Class 1 Physical Medicine device (product code ISA) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K943092 · Conair Corp. · Physical Medicine device
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Sep 1994
Decision
93d
Days
Class 1
Risk

K943092 is an FDA 510(k) clearance for the FAMILY FITNESS SHIATSU MASSAGER. Classified as Massager, Therapeutic, Electric (product code ISA), Class I - General Controls.

Submitted by Conair Corp. (Stamford, US). The FDA issued a Cleared decision on September 29, 1994 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5660 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Conair Corp. devices

Submission Details

510(k) Number K943092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1994
Decision Date September 29, 1994
Days to Decision 93 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 115d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ISA Massager, Therapeutic, Electric
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - ISA Massager, Therapeutic, Electric

All 24
Devices cleared under the same product code (ISA) and FDA review panel - the closest regulatory comparables to K943092.
D-Actor 200 Vibration Massage System
K173692 · Storz Medical AG · Apr 2018
CYNOSURE TRIACTIVE THERAPEUTIC MASSAGE SYSTEM
K030876 · Cynosure, Inc. · Jan 2004
FAMILY FITNESS SHIATSU MASSAGER
K944637 · Conair Corp. · Dec 1994
BODY FLEX
K942950 · Conair Corp. · Jul 1994
BODY SYSTEM
K942223 · Conair Corp. · Jun 1994
BODY RECHARGER
K940369 · Conair Corp. · Apr 1994