Cleared Traditional

K943092 - FAMILY FITNESS SHIATSU MASSAGER

K943092 is an FDA 510(k) clearance for FAMILY FITNESS SHIATSU MASSAGER, manufactured by Conair Corp.. The device is a Class 1 Physical Medicine device with 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

FDA 510(k) Submission Details - K943092

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.

ISA Device Classification - Class 1, General Controls

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 27
Devices cleared under the same product code (ISA) and FDA review panel - the closest regulatory comparables to K943092.
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LPG THERAPEUTIC MASSAGER, MODELS -ESI, THERAPEUTIC MASSAGER/VIBRATOR
K990445 · Lpg USA, Inc. · Jan 2000
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