Cleared Traditional

K770276 - ELECTROTHERAPY APPARATUS E.T. 720

K770276 is an FDA 510(k) clearance for ELECTROTHERAPY APPARATUS E.T. 720, manufactured by Fort & Assoc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K770276 · Fort & Assoc. · Physical Medicine device

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Mar 1977

Decision

23d

Days

Class 2

Risk

K770276 is an FDA 510(k) clearance for the ELECTROTHERAPY APPARATUS E.T. 720. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Fort & Assoc. (Mchenry, US). The FDA issued a Cleared decision on March 9, 1977 after a review of 23 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 - K770276

510(k) Number	K770276 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 14, 1977
Decision Date	March 09, 1977
Days to Decision	23 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

93d faster than avg

Panel avg: 116d · This submission: 23d

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 537

Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K770276.

STEMPLEX

K781167 · Rich-Mar Corp. · Sep 1978

GALVANATOR, MODEL 770

K781080 · Avra Corp. · Jul 1978

MUSCLE STIMULATOR, ELECTRICAL

K780133 · De Electronics · Feb 1978

ELECTRICAL SHOCK DEVICE

K760462 · Edward V. Kaufholz, Sr. · Mar 1977

STIMULATOR, ELECTRICAL MUSCLE (#MD-4)

K760547 · R. A. Fischer Co. Corp. · Feb 1977

TECA MODEL SP5/T ELECTRO-THER. STIM.

K761220 · Teca, Inc. · Dec 1976

FDA 510(k) Resources - Physical Medicine

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K770276

Fort & Assoc.

Mchenry, IL · US

Regulatory profile

1 submissions 1 cleared

100% clearance rate · Active in Physical Medicine

View all devices by Fort & Assoc. →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: March 9, 1977. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: November 2026.

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510k Database

510(k) clearances indexed 176,583

Regulatory data since 1976

FDA monthly sync November 6, 2026