Cleared Traditional

K950441 - CONAIR FAMILY FITNESS BODY ENERGY

K950441 is the FDA 510(k) clearance for CONAIR FAMILY FITNESS BODY ENERGY by Conair Corp.. It is a Class 1 Physical Medicine device (product code IRO) cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K950441 · Conair Corp. · Physical Medicine device
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Jul 1995
Decision
172d
Days
Class 1
Risk

K950441 is an FDA 510(k) clearance for the CONAIR FAMILY FITNESS BODY ENERGY. Classified as Vibrator, Therapeutic (product code IRO), Class I - General Controls.

Submitted by Conair Corp. (Stamford, US). The FDA issued a Cleared decision on July 18, 1995 after a review of 172 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5975 - 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 K950441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1995
Decision Date July 18, 1995
Days to Decision 172 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
57d slower than avg
Panel avg: 115d · This submission: 172d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IRO Vibrator, Therapeutic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5975
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 - IRO Vibrator, Therapeutic

All 18
Devices cleared under the same product code (IRO) and FDA review panel - the closest regulatory comparables to K950441.
CONAIR BODY AND SOLE
K950410 · Conair Corp. · May 1995
SQUEEZE PLAY
K943730 · Conair Corp. · Nov 1994
SONASSAGE
K923238 · Conair Corp. · Feb 1994
HEALTLH ESSENTIALS PERSONAL MASSAGER
K924431 · Conair Corp. · Oct 1993
BODYTHERM
K924519 · Conair Corp. · Oct 1993
HEALTH ESSENTIALS MAXI MASSAGER
K924581 · Conair Corp. · Oct 1993