Cleared Traditional

K781319 - THERAPY APPAR. 422 INTERFERENTIAL

K781319 is an FDA 510(k) clearance for THERAPY APPAR. 422 INTERFERENTIAL, manufactured by General Theraphysical, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K781319 · General Theraphysical, Inc. · Physical Medicine device
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Oct 1978
Decision
64d
Days
Class 2
Risk

K781319 is an FDA 510(k) clearance for the THERAPY APPAR. 422 INTERFERENTIAL. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by General Theraphysical, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 3, 1978 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - 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.

FDA 510(k) Submission Details - K781319

510(k) Number K781319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1978
Decision Date October 03, 1978
Days to Decision 64 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
52d faster than avg
Panel avg: 116d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IPF Device Classification - Class 2, Special Controls

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - IPF Stimulator, Muscle, Powered

All 537
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K781319.
MYO-STIM
K781239 · Med General · Nov 1978
MUSCLE STIMULATION APPARATUS
K781315 · General Theraphysical, Inc. · Oct 1978
DYNATRON 406 ELECTROTHERAPY APPARATUS
K781318 · General Theraphysical, Inc. · Oct 1978
MUSCLE STIMULATOR, ELECTRICAL
K781113 · Rich-Mar Corp. · Sep 1978
MUSCLE STIMULATOR, ELECTRONIC
K781139 · Thor Medical Instruments, Inc. · Sep 1978
STEMPLEX
K781167 · Rich-Mar Corp. · Sep 1978
K781319 · THERAPY APPAR. 422 INTERFERENTIAL
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