Cleared Traditional

K913444 - GLOBALCARE EMS

K913444 is an FDA 510(k) clearance for GLOBALCARE EMS, manufactured by Globalcare Intl., Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K913444 · Globalcare Intl., Inc. · Physical Medicine device
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Oct 1991
Decision
80d
Days
Class 2
Risk

K913444 is an FDA 510(k) clearance for the GLOBALCARE EMS. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Globalcare Intl., Inc. (Holyoke, US). The FDA issued a Cleared decision on October 21, 1991 after a review of 80 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.

View all Globalcare Intl., Inc. devices

FDA 510(k) Submission Details - K913444

510(k) Number K913444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1991
Decision Date October 21, 1991
Days to Decision 80 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 115d · This submission: 80d
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 273
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K913444.
MEDTRONIC RESPOND III NEUROMUSCULAR STIMULATOR
K920436 · Medtronic Vascular · May 1992
RICH-MAR IFV 1000
K914539 · Rich-Mar Corp. · Dec 1991
EMS300, EMS400, EMS8000
K912642 · Skylark Device Co., Ltd. · Dec 1991
REVISED HIGH VOLTAGE STIMULATOR INTELECT 150
K902599 · Chattanooga Group, Inc. · Oct 1990
RICH-MAR BP-2000 ELECTRICAL MUSCLE STIMULA. UNIT
K901779 · Rich-Mar Corp. · Jun 1990
SIEMENS STEREODYNATOR 828
K881431 · Elmed, Inc. · Apr 1990