Cleared Traditional

INFRADERM (K911727) - FDA 510(k) Clearance

Also marketed or referenced as:
TOUCH 'N TONE PLUS

Class I Physical Medicine device.

K911727 · Conair Corp. · Physical Medicine device
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Optimized for regulatory review, auditing and printing
Feb 1994
Decision
1045d
Days
Class 1
Risk

K911727 is an FDA 510(k) clearance for the INFRADERM. 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 February 25, 1994 after a review of 1045 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Conair Corp. devices

Submission Details

510(k) Number K911727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1991
Decision Date February 25, 1994
Days to Decision 1045 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
930d slower than avg
Panel avg: 115d · This submission: 1045d
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

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