Cleared Traditional

K942223 - BODY SYSTEM

K942223 is the FDA 510(k) clearance for BODY SYSTEM by Conair Corp.. It is a Class 1 Physical Medicine device (product code ISA) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K942223 · Conair Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
34d
Days
Class 1
Risk

K942223 is an FDA 510(k) clearance for the BODY SYSTEM. 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 June 9, 1994 after a review of 34 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

Submission Details

510(k) Number K942223 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received May 06, 1994
Decision Date June 09, 1994
Days to Decision 34 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
81d faster than avg
Panel avg: 115d · This submission: 34d
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 K942223.
FAMILY FITNESS SHIATSU MASSAGER
K944637 · Conair Corp. · Dec 1994
FAMILY FITNESS SHIATSU MASSAGER
K943092 · Conair Corp. · Sep 1994
BODY FLEX
K942950 · Conair Corp. · Jul 1994
BODY RECHARGER
K940369 · Conair Corp. · Apr 1994
BODY RELAXER
K926339 · Conair Corp. · Mar 1994
OMRON MASSAGER MODEL HM-45
K935459 · Omron Healthcare, Inc. · Mar 1994