Cleared Traditional

K252712 - STIMPOD NMS460 Nerve Stimulator

K252712 is an FDA 510(k) clearance for STIMPOD NMS460 Nerve Stimulator, manufactured by Algiamed Technologies USA, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 274-day FDA review.

K252712 · Algiamed Technologies USA, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
274d
Days
Class 2
Risk

K252712 is an FDA 510(k) clearance for the STIMPOD NMS460 Nerve Stimulator. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Algiamed Technologies USA, Inc. (Lake Mary, US). The FDA issued a Cleared decision on May 28, 2026 after a review of 274 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 Algiamed Technologies USA, Inc. devices

FDA 510(k) Submission Details - K252712

510(k) Number K252712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2025
Decision Date May 28, 2026
Days to Decision 274 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
126d slower than avg
Panel avg: 148d · This submission: 274d
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 254
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K252712.
actiTENS mini
K252767 · Sublimed · Jan 2026
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K252236 · N & C Holdings, LLC · Aug 2025
Unipro (K-UNIPRO-US)
K232441 · Tenscare, Ltd. · Aug 2024
TENSWave
K241228 · Zynex Medical Officer · 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