Cleared Traditional

K070931 - MODEL PMT850

K070931 is an FDA 510(k) clearance for MODEL PMT850, manufactured by Promedtek, Inc.. The device is a Class 2 Physical Medicine device with product code ILX cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K070931 · Promedtek, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
51d
Days
Class 2
Risk

K070931 is an FDA 510(k) clearance for the MODEL PMT850. Classified as Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat (product code ILX), Class II - Special Controls.

Submitted by Promedtek, Inc. (Washington, US). The FDA issued a Cleared decision on May 24, 2007 after a review of 51 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 - K070931

510(k) Number K070931 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2007
Decision Date May 24, 2007
Days to Decision 51 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 116d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILX Device Classification - Class 2, Special Controls

Product Code ILX Diathermy, Shortwave, For Use Other Than 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 - ILX Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat

All 13
Devices cleared under the same product code (ILX) and FDA review panel - the closest regulatory comparables to K070931.
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MAGNETIC RESONANCE THERAPY DEVICE
K903675 · Mrt, Inc. · Jan 1991
K070931 · MODEL PMT850
Download PDF FDA Summary Promedtek, Inc.