Cleared Traditional

K820953 - EF2000

K820953 is an FDA 510(k) clearance for EF2000, manufactured by Squire, Sanders & Dempsey. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K820953 · Squire, Sanders & Dempsey · Physical Medicine device
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Jul 1982
Decision
107d
Days
Class 2
Risk

K820953 is an FDA 510(k) clearance for the EF2000. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Squire, Sanders & Dempsey (Mchenry, US). The FDA issued a Cleared decision on July 22, 1982 after a review of 107 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K820953

510(k) Number K820953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1982
Decision Date July 22, 1982
Days to Decision 107 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
9d faster than avg
Panel avg: 116d · This submission: 107d
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 K820953.
EXER-STIM CONTROLLER
K822056 · Th Charters, Inc. · Oct 1982
MYO-TONE, INC. SYSTEM-80
K822250 · Myo-Tone, Inc. · Sep 1982
COMPLY NEUROMUSCULAR STIMULATOR
K822284 · Omega-Med Intl., Inc. · Sep 1982
P6S ATHLETIC
K821449 · Squire, Sanders & Dempsey · Jul 1982
BX-1000 ISOMATIC
K820080 · Bloomex International, Inc. · Jul 1982
ELECTRONIC MUSCLE EXERCISER
K821110 · Bloomex International, Inc. · Jul 1982
K820953 · EF2000
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