Cleared Traditional

K020846 - ULTIMA TENS XL-A1

K020846 is an FDA 510(k) clearance for ULTIMA TENS XL-A1, 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 67-day FDA review.

K020846 · Tenscare, Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
67d
Days
Class 2
Risk

K020846 is an FDA 510(k) clearance for the ULTIMA TENS XL-A1. 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 May 21, 2002 after a review of 67 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 - K020846

510(k) Number K020846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2002
Decision Date May 21, 2002
Days to Decision 67 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
82d faster than avg
Panel avg: 149d · This submission: 67d
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 K020846.
NT MEDITENS PLUS, TYPE 290
K014020 · Bio-Medical Research, Ltd. · Jul 2002
APEX MEDICAL DIGITAL TENS TS1211, TS1212
K021755 · Apex Medical Corp. · Jun 2002
CEFAR MEDICAL AB CEFAR PRIMO
K020803 · Cefar Medical AB · Jun 2002
SANIDAD HEALTH-UP TENS MP-73725
K014126 · Roc Chinese-European Industrial Research Society · May 2002
DIGI-PRO TENS MODEL WL-2203 AND WL-2205
K021359 · Well-Life Healthcare, Inc. · Apr 2002
TRUWAVE
K013210 · Dan Med, Inc. · Apr 2002