Cleared Traditional

PROMAX-XP, TENS AND MICROCURRENT DEVICE (K011017) - FDA 510(k) Clearance

Also marketed or referenced as:
PROMAX-TENS, TENS DEVICE PROMAX-LIBRA, TENS DEVICE PROMAX-MC, MICROCURRENT

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K011017 · Rehabilicare, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
173d
Days
Class 2
Risk

K011017 is an FDA 510(k) clearance for the PROMAX-XP, TENS AND MICROCURRENT DEVICE. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Rehabilicare, Inc. (New Brighton, US). The FDA issued a Cleared decision on September 24, 2001 after a review of 173 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Rehabilicare, Inc. devices

Submission Details

510(k) Number K011017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2001
Decision Date September 24, 2001
Days to Decision 173 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 148d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 605
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K011017.
STIMPOD NMS460 Nerve Stimulator
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actiTENS mini
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Unipro (K-UNIPRO-US)
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TENSWave
K241228 · Zynex Medical Officer · Aug 2024
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K233046 · Oriental Inspiration Limited · Apr 2024