Cleared Traditional

K871647 - STIMULATOR, ULTRASOUND AND MUSCLE

K871647 is an FDA 510(k) clearance for STIMULATOR, manufactured by Amy West. The device is a Class 2 Physical Medicine device with product code IMG cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K871647 · Amy West · Physical Medicine device
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Jun 1987
Decision
62d
Days
Class 2
Risk

K871647 is an FDA 510(k) clearance for the STIMULATOR, ULTRASOUND AND MUSCLE. Classified as Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat (product code IMG), Class II - Special Controls.

Submitted by Amy West (Worcester, US). The FDA issued a Cleared decision on June 29, 1987 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5860 - 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.

View all Amy West devices

FDA 510(k) Submission Details - K871647

510(k) Number K871647 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 28, 1987
Decision Date June 29, 1987
Days to Decision 62 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
53d faster than avg
Panel avg: 115d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IMG Device Classification - Class 2, Special Controls

Product Code IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5860
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 - IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

All 44
Devices cleared under the same product code (IMG) and FDA review panel - the closest regulatory comparables to K871647.
ULTRA (THERAPEUTIC ULTRASOUND DEVICE)
K895690 · Excel Tech. , Ltd. · Feb 1990
SIEMENS SONODYNATOR 834, ULTRASOUND/STIMULATION
K872909 · Elmed, Inc. · Jan 1988
SONOPULS 464, ULTRASOUND THERAPY EQUIPMENT
K872394 · Henley Intl. · Sep 1987
RICH-MAR DELTA 330 HV
K844217 · Rich-Mar Corp. · Nov 1984
INTELECT MODEL 700
K813594 · Chattanooga Group, Inc. · Feb 1982
RICH-MAR HV II SELECT-A-PULSE
K810526 · Rich-Mar Corp. · Apr 1981