Cleared Traditional

K932868 - THERATOUCH 4.7

K932868 is the FDA 510(k) clearance for THERATOUCH 4.7 by Rich-Mar Corp.. It is a Class 2 Neurology device (product code LIH) cleared through the Traditional 510(k) pathway after a 410-day FDA review.

K932868 · Rich-Mar Corp. · Neurology device
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Jul 1994
Decision
410d
Days
Class 2
Risk

K932868 is an FDA 510(k) clearance for the THERATOUCH 4.7. Classified as Interferential Current Therapy (product code LIH), Class II - Special Controls.

Submitted by Rich-Mar Corp. (Inola, US). The FDA issued a Cleared decision on July 29, 1994 after a review of 410 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology 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 Neurology submissions.

View all Rich-Mar Corp. devices

Submission Details

510(k) Number K932868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1993
Decision Date July 29, 1994
Days to Decision 410 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
262d slower than avg
Panel avg: 148d · This submission: 410d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LIH Interferential Current Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - LIH Interferential Current Therapy

All 21
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