Cleared Traditional

K023997 - TENSCARE ULTIMA NMS/EMS

K023997 is an FDA 510(k) clearance for TENSCARE ULTIMA NMS/EMS, manufactured by Tenscare, Ltd.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K023997 · Tenscare, Ltd. · Physical Medicine device
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Mar 2003
Decision
90d
Days
Class 2
Risk

K023997 is an FDA 510(k) clearance for the TENSCARE ULTIMA NMS/EMS. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Tenscare, Ltd. (Timperley, Cheshire, GB). The FDA issued a Cleared decision on March 3, 2003 after a review of 90 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.

View all Tenscare, Ltd. devices

FDA 510(k) Submission Details - K023997

510(k) Number K023997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2002
Decision Date March 03, 2003
Days to Decision 90 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
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 166
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K023997.
AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE
K032941 · Rich-Mar Corp. · Oct 2003
ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS03-1
K031427 · Biomedical Life Systems, Inc. · Aug 2003
SYS*STIM 208 AND 208A
K031017 · Mettler Electronics Corp. · May 2003
ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS02-5
K021588 · Biomedical Life Systems, Inc. · Feb 2003
DIGITAL ELECTRICAL MUSCLE STIMULATOR, MODEL EV-807 DIGITAL EMS
K020750 · Everyway Medical Instruments Co.,Ltd · Oct 2002
NEUROTECH MEDISTIM PLUS, TYPE 291
K014019 · Bio-Medical Research, Ltd. · Jul 2002