Cleared Traditional

K781316 - PULSED AND CONTINUOUS SHORTWAVE APPAR.

K781316 is an FDA 510(k) clearance for PULSED AND CONTINUOUS SHORTWAVE APPAR., manufactured by General Theraphysical, Inc.. The device is a Class 2 Physical Medicine device with product code IMJ cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K781316 · General Theraphysical, Inc. · Physical Medicine device
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Sep 1978
Decision
58d
Days
Class 2
Risk

K781316 is an FDA 510(k) clearance for the PULSED AND CONTINUOUS SHORTWAVE APPAR.. Classified as Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat (product code IMJ), Class II - Special Controls.

Submitted by General Theraphysical, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 27, 1978 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5290 - 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 - K781316

510(k) Number K781316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1978
Decision Date September 27, 1978
Days to Decision 58 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
58d faster than avg
Panel avg: 116d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IMJ Device Classification - Class 2, Special Controls

Product Code IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5290
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 - IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat

All 44
Devices cleared under the same product code (IMJ) and FDA review panel - the closest regulatory comparables to K781316.
ULTRAMED 11S601
K842801 · Robert Bosch Corp. · Aug 1984
MEGA PULSE THERAPY UNIT
K841874 · Physio Technology, Inc. · May 1984
SIEMENS ULTRATHERM 708
K781455 · Elmed, Inc. · Dec 1978
SHORTWAVE THERAPY APPAR. CURAMED 401
K781320 · General Theraphysical, Inc. · Sep 1978
SHORTWAVE DIATHERMY MODEL 802
K780755 · Birtcher Corp. · May 1978
MAGNATHERM 2000
K771540 · Intl. Medical Electronics , Ltd. · Oct 1977
K781316 · PULSED AND CONTINUOUS SHORTWAVE APPAR.
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