FDA.report

Multi-modality physical therapy system

Definition
An assembly of electrically-powered devices designed to apply multiple different energies (e.g., light-energy, ultrasound, radio-frequency electrical stimulation, and microcurrent electrotherapy) either alone or in sequence, but not simultaneously, to noninvasively treat/prevent a variety of soft-tissue, neuromuscular, and musculoskeletal injuries/disorders (e.g., joint pain/inflammation, stiffness, soft tissue injuries, muscle atrophy, plantar fasciitis); it may in addition be used for aesthetic skin/body contouring (e.g., minimize cellulite, loose or wrinkled skin). It consists of a multi-modality control unit/generator, and dedicated applicators for the transcutaneous delivery of energy.
GUDID devices
60
Last updated
2025-02-27 11:59:47

Related Product Codes

CodeDeviceSpecialtyClassDevices
ISAMassager, Therapeutic, ElectricPhysical Medicine133
LIHInterferential Current TherapyNeurology26
NFOStimulator, Transcutaneous Electrical, Aesthetic PurposesNeurology26
IPFStimulator, Muscle, PoweredPhysical Medicine24
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine23
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology22
IMEPack, Hot Or Cold, ReusablePhysical Medicine12
PBXMassager, Vacuum, Radio Frequency Induced HeatGeneral, Plastic Surgery22
GFEBrush, Dermabrasion, PoweredGeneral, Plastic Surgery11
HCCDevice, BiofeedbackNeurology21
IMGStimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep HeatPhysical Medicine21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
06973134771402silverfoxSilverfox Corporation LimitedF-367A2025-02-19
06973134771419silverfoxSilverfox Corporation LimitedF-9052025-02-19
08720618311139Sonopuls 494Enraf-Nonius B.V.14989412025-02-11
06973134771365silverfoxSilverfox Corporation LimitedF-311A2025-01-06
06973134771372silverfoxSilverfox Corporation LimitedF-3812025-01-06
06973134771389silverfoxSilverfox Corporation LimitedF-3622025-01-06
06973134771396silverfoxSilverfox Corporation LimitedF-3652025-01-06
08809851470053eMVFitWEERO Co., Ltd.MVF-10M2024-10-22
06976510830083RAYJUHunan Ruijiu Technology Co., Ltd.RedX N12024-04-08
06976510830038PrungoHunan Ruijiu Technology Co., Ltd.RL-1002024-03-12
06976510830076PrungoHunan Ruijiu Technology Co., Ltd.RLT3002024-03-12
06973134771013silverfoxSilverfox Corporation LimitedF-311A2023-12-13
06973134771020silverfoxSilverfox Corporation LimitedF-312A2023-12-13
06973134771037silverfoxSilverfox Corporation LimitedF-311B2023-12-13
06973134771044silverfoxSilverfox Corporation LimitedF-312B2023-12-13
06973134771051silverfoxSilverfox Corporation LimitedF-313A2023-12-13
06973134771068silverfoxSilverfox Corporation LimitedF-313B2023-12-13
06973134771075silverfoxSilverfox Corporation LimitedF-314A2023-12-13
06973134771082silverfoxSilverfox Corporation LimitedF-314B2023-12-13
06973134771099silverfoxSilverfox Corporation LimitedF-315A2023-12-13
06973134771105silverfoxSilverfox Corporation LimitedF-315B2023-12-13
06973134771112silverfoxSilverfox Corporation LimitedF-316A2023-12-13
06973134771129silverfoxSilverfox Corporation LimitedF-316B2023-12-13
06973134771136silverfoxSilverfox Corporation LimitedF-317A2023-12-13
06973134771143silverfoxSilverfox Corporation LimitedF-318A2023-12-13
06973134771150silverfoxSilverfox Corporation LimitedF-318B2023-12-13
06973134771167silverfoxSilverfox Corporation LimitedF-319A2023-12-13
06973134771174silverfoxSilverfox Corporation LimitedF-319B2023-12-13
06973134771198silverfoxSilverfox Corporation LimitedF-336B2023-12-13
06973134771204silverfoxSilverfox Corporation LimitedF-3602023-12-13
06973134771211silverfoxSilverfox Corporation LimitedF-801C2023-12-13
06973134771242silverfoxSilverfox Corporation LimitedF-8062023-12-13
06973134771259silverfoxSilverfox Corporation LimitedF-821A2023-12-13
06973134771266silverfoxSilverfox Corporation LimitedF-8252023-12-13
06973134771280silverfoxSilverfox Corporation LimitedF-8342023-12-13
00860001881509BlueOnyx QuadTama Research Corp.TA10142023-11-29
00860001881516MiTAMA DeluxeTama Research Corp.TA10172023-11-29
00860001881523BlueOnyx ProTama Research Corp.TA10122023-11-29
00860001881547MiTAMA Renew PlusTama Research Corp.TA1015+2023-11-29
00860001881554MiTAMA ClearTama Research Corp.TA10182023-11-29
00860001881561BlackOnyxTama Research Corp.TA10212023-11-29
08800092020038Back 3 COLORDaeyang Medical Co., Ltd.20032023-04-26
00190446780601CHATTANOOGADJO, LLC81-50102023-04-25
00190446780618CHATTANOOGADJO, LLC81-50112023-04-25
08056590170571STARELETTRONICA PAGANI SRLSTAR2023-03-27
08056590170588STAR PLUSELETTRONICA PAGANI SRLSTAR PLUS2023-03-27
08056590170557NEVEFACEELETTRONICA PAGANI SRLNEVEFACE2023-03-26
06975980571502MEICETShanghai May Skin Information Technology Co., Ltd.MC-A92023-02-10
08056590170540NEVESKINELETTRONICA PAGANI SRLNEVESKIN2022-04-26
08056590170441CRYO T-SHOCK 4.0ELETTRONICA PAGANI SRLCRYO T-SHOCK 4.02022-04-24
10660584000017Dynatron Solaris Plus 709Dynatronics CorporationD719T2016-09-24
10660584000024Dynatron Solaris Plus 708Dynatronics CorporationD718T2016-09-24
10660584000031Dynatron Solaris Plus 707Dynatronics CorporationD7172016-09-24
10660584000048Dynatron Solaris Plus 706Dynatronics CorporationD716T2016-09-24
10660584000055Dynatron Solaris Plus 705Dynatronics CorporationD715T2016-09-24
10660584000109Dynatron 25 Series 925BDynatronics CorporationD925T2016-09-24
10660584000116Dynatron 25 Series 825BDynatronics CorporationD825T2016-09-24
10660584000123Dynatron 25 Series 625BDynatronics CorporationD625T2016-09-24
10660584000130Dynatron 25 Series 525BDynatronics CorporationD525T2016-09-24
10660584000338Dynatron Solaris Plus 709Dynatronics CorporationD7192016-09-24