BEUDAMED
    Product Code: NGX FDA class 2 21 CFR 890.5850

    Stimulator, Muscle, Powered, For Muscle Conditioning

    Physical Medicine

    The Stimulator, Muscle, Powered, For Muscle Conditioning (product code NGX) is a powered physical medicine device used to apply electrical stimulation to muscles for conditioning, toning, or rehabilitation purposes, as distinct from devices intended for pain management or therapeutic neuromuscular stimulation. Per its definition, it is used for non-therapeutic muscle conditioning applications. It is classified as an FDA Class 2 device within the Physical Medicine specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.

    View on FDA
    510(k)s
    162
    FEI Numbers
    191
    Registration Numbers
    191
    Unique Applicants
    93
    Years Active
    25

    Basic Information

    Product Code
    NGX
    Device Class
    FDA class 2
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Review Panel
    PM
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    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.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 162 510(k) clearances via K numbers.

    K Number Device Name
    K253926 Diacore
    K253636 Zionic Pro Max (EMS)
    K253408 CoolTone
    K252154 Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)
    K253478 Motive™ Muscle Stimulator for Lower Back (OT01-1003)
    K251594 truFlex
    K251706 TENS and EMS Unit
    K251378 CoolTone
    K251746 Pure Impact
    K250759 3 in 1 TENS UNIT
    K242926 XBody Go USA, XBody Pro USA
    K250038 Muscle Stimulator Device (PZ-100)
    K243165 Limfa Therapy System (Limfa Therapy)
    K250146 SofWave System
    K243763 Wireless TENS & EMS Unit
    K241601 EMS (FlexPulse, MagnaCore, Magnetika)
    K243511 OTC TENS & EMS Unit
    K233770 Pepper EMS Training System
    K242787 Tens & Ems Device (TU1080)
    K232982 EMS Sculpt Machine
    K242186 Neo Sculptor (OF-NEO001)
    K241685 SofWave System
    K240347 PTG-05
    K230711 Pain Therapy Device(Model: P.T.S-X)
    K232181 Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13)
    K232409 Electromagnetic Stimulation Systems
    K233070 Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)
    K231789 Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII)
    K222400 Coresculpt & Magsculpt
    K233035 Electronic Muscle Stimulator (Model MP01)
    K233492 EMS Neck Massager
    K233470 DEKA LILY
    K230024 HI-EMT MAGSHAPE
    K220938 Nova HD+
    K231318 Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet)
    K231136 Fitness Belt (Model: KLT-07)
    K231368 Bemer Therapy System Evo
    K230261 Gnesis EMS Plus
    K222875 Powered Muscle Stimulator (Model name:MagGraver F200)
    K222386 Visionbody
    K223797 Neuro20 Pro System
    K221200 XBody Go USA, XBody Pro USA
    K212866 truSculpt flex
    K213748 CoreLevee
    K221498 Miha Bodytec II
    K211298 WiEMSpro
    K212413 I-Motion
    K220601 CoolTone
    K210825 Revitive Medic Coach (Model Number 5575AQ)
    K211942 Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)
    K212948 Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I)
    K200545 Legend Pro DMA
    K202148 E-Fit Infinity System (EF-2090 Controller and EF-100 Unit)
    K202638 Pain Therapy Device
    K201257 MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400)
    K201975 miha bodytec II
    K203513 SLENDERTONE Evolve Abs, Type 735
    K210174 BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set
    K202653 Gymform Total ABS
    K200382 BTL-703-2
    K201239 NuEra Tight Family, EMS Model
    K201354 TENS & PMS
    K201653 Compex Sport Elite 3.0
    K201845 Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)
    K182020 Portable Electro-Stimulation Therapy Device
    K191938 FitRelief TENS&EMS Wireless Device
    K201131 firefly T-2
    K192887 Revitive Medic Plus, Revitive Advanced 2
    K192039 Torc Body
    K190966 Katalyst Training System
    K192161 FastFit EMS System
    K192940 CoolTone
    K192264 HIVOX Spopad EMS SP-911, SP-921
    K191181 NXPRO Neuromuscular Electrical Stimulation Device
    K183103 EMS Belt (Model MC0485)
    K182794 BionicGym Powered Muscle Stimulator
    K190924 Revitive Medic Plus, Revitive Advanced 2
    K190456 BTL 799-2L
    K182963 emFieldPro
    K182519 Miha Bodytec II
    K181419 FLIX-EMS
    K190038 Xbody Newave USA
    K183454 Tyece OTC EMS System
    K182440 Body System
    K181955 WiEMSpro
    K180688 SLENDERTONE CoreFit Abs 8, Type 734
    K182106 BTL 799-2T
    K181728 Muscle Trainer
    K181199 Katalyst Mark 1 Muscle Stimulation System Model 2
    K180813 BTL 799-2
    K180279 Silk'n MODEL H5003 device
    K172876 PowerDot PD-01M
    K172241 Tyece OTC EMS System, Model EM35
    K171035 Katalyst Mark 1 Muscle Stimulation System
    K162744 Everyway OTC EMS, Model EV-805
    K171092 XiniWave II Model ECS322P
    K170918 Compex Sport Elite
    K170903 Compex Wireless USA
    K160323 FlowKeepers
    K151834 BEMER Classic Set, BEMER Pro-Set
    K163165 AM-100
    K152420 AK Body Toning Device
    K161974 SLENDERTONE® Connect Abs, Type 570
    K152480 Revitive Medic; Revitive MV; Revitive LV
    K151722 Slim UP ULTRA
    K151903 Slendertone connect Abs
    K150078 PowerDot(R) PD-01 Muscle Stimulator (with PowerDot(R) Mobile Application)
    K143737 EM25 - glute toning device
    K141919 VEINOPLUS SPORT NEUROMUSCULAR STIMULATOR
    K142055 GYMFORM ABS & CORE
    K143551 Compex Wireless USA
    K143207 Revitive IX (OTC)
    K143059 TAMTEC-HANA TENS / EMS (Sport Muscle Stimulator)
    K141921 HIVOX SPOPAD EMS
    K133225 E-FIT EF-1280 EMS MACHINE
    K133108 FIT BELT
    K133965 OTC EMS STIMULATOR
    K134001 FIREFLY
    K132179 ARASYS
    K130723 FDES106 MINI TENS&EMS DEVICE,FDES106 MULTI-FUNCTION MINI TENS&EMS DEVICE,FDES105 PAIN RELIEF PLASTER,FDES107 ABDOMINAL
    K122393 TG-BODY MI&BODY S-TRAINER
    K130074 GYMFORM ABS-A-ROUND
    K123075 BUTTOCK MUSCLE STIMULATOR MODEL WL-2413B; BUTTOCK MUSCLE STIMULATOR MODE WL-2413E
    K123158 ION MAGNUM GENIUS
    K131291 TORC BODY
    K121719 SM TENS & PMS
    K122414 AB COMMAND DUAL CHANNEL FITNESS BELT
    K111781 GYMFORM DUAL FLEX BELT MODEL WB-162
    K111476 CONTOUR TECHNOLOGY MUSCLE STIMULATOR
    K110057 MINI MASSEUSE
    K102933 GEM-TONE BODY TRAINING SYSTEM
    K102926 GEMORE MUSCLE CONDITIONER;
    K102786 WELL-LIFE OTC EMS SYSTEM
    K102295 X2ABS DUAL CHANNEL FITNESS BELT
    K093999 ARP POV SPORT
    K100556 SLENDERTONE FLEX MAX, MODEL 517 US
    K092476 SPORT-ELEC BODY CONTROL SYSTEM, MODEL 4M
    K100320 SLENDERTONE SYSTEM ULTRA MODEL E70/X70
    K092142 SPORT-ELEC BODY CONTROL SYSTEM BS
    K093368 BUTTERFLY TONER MODEL GYM070
    K091865 SPORT-ELEC BODY CONTROL SYSTEM
    K091833 GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE.
    K081998 H-WAVE SPORT
    K083140 COMPEX SPORT PLUS
    K083164 SYSTEM-ARMS, MODELS 390, X60
    K081026 BODY CONTROL SYSTEM FAMILY, BODY CONTROL DUO AND CT5
    K071666 SLENDERTONE ENERVIVE, MODEL 561
    K072168 OTC ABDOMEN & THIGH SYSTEM, MODEL: WL-2410, WL-2411 AND WL-2412
    K072553 SYSTEM-ARMS, MODEL 390,E60
    K072294 SYSTEM-MINI, MODELS: 390, E30
    K061914 SPORT-ELEC, MODELS DUO CT5 SLIMNESS AND CT5 SLIMNESS
    K061632 GLOBUS PREMIUM MUSCLE STIMULATOR
    K070142 SLENDERTONE SYSTEM ABS, MODELS 390, E10, X10; SLENDERTONE SYSTEM SHORTS, MODELS 390, E20
    K062439 POWERTONE, MODEL PT-11
    K052969 SLENDERTONE GYMBODY, MODEL 512-01
    K031611 P4-FITNESS
    K030708 SLENDERTONE FLEX ABDOMINAL TRAINING SYSTEM, TYPE 515
    K022855 SLENDERTONE FLEX BOTTOM & THIGH TONING SYSTEM, TYPE 511
    K020429 AB BELT PRO
    K020427 AB BELT
    K011880 COMPEX SPORT
    K010335 SLENDERTONE FLEX, MODEL, 512

    FEI Numbers

    This FDA classification entry is associated with 191 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 191 registration numbers. Click on an entry to view related FDA registrations.