FDA.reportPublic FDA data

Focused Shock Wave Therapy Device

Primary DI
06976287180886
Brand
Focused Shock Wave Therapy Device
Company
Guangzhou Longest Medical Technology Co., Ltd.
Model
LGT-2520AP
Published
2024-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ISAMassager, Therapeutic, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06976287180886PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06976287180886069762871808866976287180886

GMDN Terms#

Term, Definition table
TermDefinition
Electromechanical orthopaedic extracorporeal shock wave therapy systemAn assembly of devices designed to provide electromechanical orthopaedic extracorporeal shock wave therapy (OEST) to treat musculoskeletal disorders. It is typically portable and includes a control unit that uses an electrical current to create kinetic energy (e.g., with a coil gun) which is transferred to a patient's body upon contact (e.g., with a hand-held surface applicator) to produce mechanical shock waves at selected amplitudes and frequencies. It is used to treat soft-tissue pain and inflammation near bones, disorders such as tendinopathies and lateral/medial epicondylitis, and to stimulate osteogenesis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
550274189
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06976287180787Active Passive Trainer for Upper and Lower LimbsLGT-5100P2026-04-14
06976287181012Compression Therapy DeviceLGT-2210DS2026-04-14
06976287180336Portable Electro Stimulation Therapy DeviceLGT-2320ME2026-04-02
06976287180343Portable Electro Stimulation Therapy DeviceLGT-2320BE2026-04-02
06976287180350Portable Electro Stimulation Therapy DeviceLGT-2320SP2026-04-02
06976287181005Deep Oscillation Therapy DeviceLGT-2360S2024-09-20
06976287180855Electrostatic Oscillation Therapy DeviceLGT-2360S2024-07-18
06976287180992PowerPulse DeviceLGT-2520AP2024-09-20
06976287180862Radial Pressure Pulse Therapy DeviceLGT-2500S, config II2024-07-22
06976287180879Radial Pressure Pulse Therapy DeviceLGT-2500S, config III2024-07-22
06976287180466Radial Pressure Pulse Therapy DeviceLGT-2500X2024-07-18
06976287180794Compression Therapy DeviceLGT-2200SP2024-07-18
06976287180800Portable Electro-Stimulation Therapy DeviceLGT-231(US)2024-07-18
06976287180817Portable Electro-Stimulation Therapy DeviceLGT-232(US)2024-07-18
06976287180824Portable Electro-Stimulation Therapy DeviceLGT-2332024-07-18
06976287180831Portable Electro-Stimulation Therapy DeviceLGT-235(US)2024-07-18
06976287180848Active Passive Trainer for Upper and Lower LimbsLGT-5100D2024-07-18

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