Cleared Traditional

K820938 - HAWKINS ELECTROKINETIC BODY ACTIVATING

K820938 is an FDA 510(k) clearance for HAWKINS ELECTROKINETIC BODY ACTIVATING, manufactured by Leisure Way. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K820938 · Leisure Way · Physical Medicine device
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Jun 1982
Decision
67d
Days
Class 2
Risk

K820938 is an FDA 510(k) clearance for the HAWKINS ELECTROKINETIC BODY ACTIVATING. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Leisure Way (Mchenry, US). The FDA issued a Cleared decision on June 11, 1982 after a review of 67 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 - K820938

510(k) Number K820938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1982
Decision Date June 11, 1982
Days to Decision 67 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
49d faster than avg
Panel avg: 116d · This submission: 67d
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 529
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K820938.
BX-1000 ISOMATIC
K820080 · Bloomex International, Inc. · Jul 1982
ELECTRONIC MUSCLE EXERCISER
K821110 · Bloomex International, Inc. · Jul 1982
HETERODYNAMIC
K821157 · Birtcher Corp. · Jun 1982
THERATRONIC STIMULATOR
K820782 · Theratronics, Inc. · Jun 1982
ELECTRICAL MUSCLE STIMULATOR
K820884 · Nitron Electronics · Apr 1982
CLINIC 2000 MODEL MULTI-FRECODYN DEVICE
K820784 · Dimeco · Apr 1982
K820938 · HAWKINS ELECTROKINETIC BODY ACTIVATING
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