Cleared Traditional

SofWave System (K250146) - FDA 510(k) Clearance

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

K250146 · Sofwave Medical, Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
87d
Days
Class 2
Risk

K250146 is an FDA 510(k) clearance for the SofWave System. Classified as Stimulator, Muscle, Powered, For Muscle Conditioning (product code NGX), Class II - Special Controls.

Submitted by Sofwave Medical, Ltd. (Yokneam Iiit, IL). The FDA issued a Cleared decision on April 18, 2025 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.5850 - 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 Sofwave Medical, Ltd. devices

Submission Details

510(k) Number K250146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2025
Decision Date April 18, 2025
Days to Decision 87 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
61d faster than avg
Panel avg: 148d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
Definition A Powered Muscle Stimulator For Muscle Conditioning Is A Device Used For Other Than Medical Purposes To Apply An Electrical Current To Electrodes On A Person's Skin To Temporarily Affect The Stimulated Muscle's Contractile Properties, Force Output, And/or Fatigue Resistance. Unlike The Classified Powered Muscle Stimulator Devices Intended For Use In Physical Medicine And Rehabilitation, This Device Is Not Intended For Use In Patients With Medical Conditions And Is Intended Only For Muscle Conditioning Purposes.
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 Consultant

Hogan Lovells US LLP
Janice Hogan

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 - NGX Stimulator, Muscle, Powered, For Muscle Conditioning

All 93
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