Cleared Traditional

K003591 - TENSCARE, MODEL TENS XL-2

K003591 is an FDA 510(k) clearance for TENSCARE, manufactured by Tenscare, Ltd.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K003591 · Tenscare, Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
85d
Days
Class 2
Risk

K003591 is an FDA 510(k) clearance for the TENSCARE, MODEL TENS XL-2. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Tenscare, Ltd. (Timperley, Cheshire, GB). The FDA issued a Cleared decision on February 14, 2001 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology 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 Tenscare, Ltd. devices

FDA 510(k) Submission Details - K003591

510(k) Number K003591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2000
Decision Date February 14, 2001
Days to Decision 85 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 149d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZJ Device Classification - Class 2, Special Controls

Product Code GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
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 Neurology devices follow this clearance model.

Regulatory Peers - GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

All 332
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K003591.
YORAMED, MODEL T-202
K002297 · United Yoram Distributors, Inc. · Mar 2001
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MEDRELIEF
K003507 · Healthonics, Inc. · Feb 2001
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K993229 · Johari Electro-Tech Co. · Feb 2001
STIMATE N601 TENS
K003487 · Everyway Medical Instruments Co.,Ltd · Jan 2001
HMS NEUROMUSCULAR STIMULATOR, MODEL HMS 3
K003231 · Home Medical Services · Jan 2001