Cleared Abbreviated

K241228 - TENSWave (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K241228 · Zynex Medical Officer · Physical Medicine device
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Aug 2024
Decision
117d
Days
Class 2
Risk

K241228 is an FDA 510(k) clearance for the TENSWave. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Zynex Medical Officer (Englewood, US). The FDA issued a Cleared decision on August 27, 2024 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 882.5890 - the FDA physical medicine device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Zynex Medical Officer devices

Submission Details

510(k) Number K241228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2024
Decision Date August 27, 2024
Days to Decision 117 days
Submission Type Abbreviated
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 115d · This submission: 117d
Pathway characteristics
Standards-based clearance path.

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 Physical Medicine devices follow this clearance model.

Regulatory Consultant

Zynex
Harrison Tanksley

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 604
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K241228.
actiTENS mini
K252767 · Sublimed · Jan 2026
CP Relief Wand Rx - TENS/NMES
K252236 · N & C Holdings, LLC · Aug 2025
Unipro (K-UNIPRO-US)
K232441 · Tenscare, Ltd. · Aug 2024
Electrical Neuromuscular Stimulator, Cure Trio
K233046 · Oriental Inspiration Limited · Apr 2024
Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)
K222879 · Wuxi Jiajian Medical Instrument Co., Ltd. · Jan 2023
iRelieve Microcurrent Pain Relief System
K212618 · Fast Track Technologies, Inc. · Sep 2022