Cleared Traditional

HI-EMT MAGSHAPE (K230024) - FDA 510(k) Clearance

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

K230024 · Beijing Sano Laser S&T Development Co.,Ltd · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2023
Decision
245d
Days
Class 2
Risk

K230024 is an FDA 510(k) clearance for the HI-EMT MAGSHAPE. Classified as Stimulator, Muscle, Powered, For Muscle Conditioning (product code NGX), Class II - Special Controls.

Submitted by Beijing Sano Laser S&T Development Co.,Ltd (Bejing, CN). The FDA issued a Cleared decision on September 6, 2023 after a review of 245 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - the FDA physical medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Beijing Sano Laser S&T Development Co.,Ltd devices

Submission Details

510(k) Number K230024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2023
Decision Date September 06, 2023
Days to Decision 245 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 115d · This submission: 245d
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 Physical Medicine devices follow this clearance model.

Regulatory Consultant

Microkn Medical Technology Service (Shanghai) Co., Ltd.
Heather Wang

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
Devices cleared under the same product code (NGX) and FDA review panel - the closest regulatory comparables to K230024.
Electronic Muscle Stimulator (Model MP01)
K233035 · Shenzhen Hengbosi Industrial Co., Ltd. · Jan 2024
EMS Neck Massager
K233492 · Xiamen Comfier Technology Co., Ltd. · Dec 2023
DEKA LILY
K233470 · El.En S.P.A. · Dec 2023
Nova HD+
K220938 · Aura Wellness, LLC · Aug 2023
Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet)
K231318 · Beijing Adss Development Co., Ltd. · Jul 2023
Fitness Belt (Model: KLT-07)
K231136 · Shenzhen Kelutongda Industrial Co., Ltd. · Jun 2023