Cleared Special

K010665 - TRANSAMERICA DIGITAL EMS

K010665 is an FDA 510(k) clearance for TRANSAMERICA DIGITAL EMS, manufactured by Transamerica Medical Systems. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Special 510(k) pathway after a 52-day FDA review.

K010665 · Transamerica Medical Systems · Physical Medicine device
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Apr 2001
Decision
52d
Days
Class 2
Risk

K010665 is an FDA 510(k) clearance for the TRANSAMERICA DIGITAL EMS. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Transamerica Medical Systems (Holyoke, US). The FDA issued a Cleared decision on April 27, 2001 after a review of 52 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Transamerica Medical Systems devices

FDA 510(k) Submission Details - K010665

510(k) Number K010665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2001
Decision Date April 27, 2001
Days to Decision 52 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 115d · This submission: 52d
Pathway characteristics
Modification to existing cleared device.

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 236
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K010665.
MS104A, NEWMINI II (EMS-II), MODEL AP-101050T AND MEDTRIM (EMS-V), MODEL AP-102050T
K002336 · Apex Medical Corp. · Jul 2001
SMITH & NEPHEW RESTIM
K003596 · Smith & Nephew, Inc. · Jun 2001
VECTORSURGE 5, MODEL VS-500
K002058 · Metron Medical Australia, Pty, Ltd. · May 2001
VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT MODEL VS 460
K003260 · Metron Medical Australia, Pty, Ltd. · Feb 2001
RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS DEVICE
K000808 · Rich-Mar Corp. · Aug 2000
CONTROL SOLUTIONS INC, MODEL CS3101
K993420 · Control Solutions, Inc. · Jul 2000