Cleared Traditional

K944637 - FAMILY FITNESS SHIATSU MASSAGER

K944637 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 83-day FDA review.

K944637 · Conair Corp. · Physical Medicine device
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Dec 1994
Decision
83d
Days
Class 1
Risk

K944637 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 December 13, 1994 after a review of 83 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 K944637 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 21, 1994
Decision Date December 13, 1994
Days to Decision 83 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
32d faster than avg
Panel avg: 115d · This submission: 83d
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
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