Cleared Traditional

K942950 - BODY FLEX

K942950 is an FDA 510(k) clearance for BODY FLEX, 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 33-day FDA review.

K942950 · Conair Corp. · Physical Medicine device
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Jul 1994
Decision
33d
Days
Class 1
Risk

K942950 is an FDA 510(k) clearance for the BODY FLEX. 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 July 26, 1994 after a review of 33 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Conair Corp. devices

FDA 510(k) Submission Details - K942950

510(k) Number K942950 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 23, 1994
Decision Date July 26, 1994
Days to Decision 33 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 115d · This submission: 33d
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 K942950.
LPG THERAPEUTIC MASSAGER, MODELS -ESI, THERAPEUTIC MASSAGER/VIBRATOR
K990445 · Lpg USA, Inc. · Jan 2000
FAMILY FITNESS SHIATSU MASSAGER
K944637 · Conair Corp. · Dec 1994
FAMILY FITNESS SHIATSU MASSAGER
K943092 · Conair Corp. · Sep 1994
BODY SYSTEM
K942223 · Conair Corp. · Jun 1994
BODY RECHARGER
K940369 · Conair Corp. · Apr 1994
BODY RELAXER
K926339 · Conair Corp. · Mar 1994