FDA.reportPublic FDA data

Radial Pressure Pulse Therapy Device

Primary DI
06971410780261
Brand
Radial Pressure Pulse Therapy Device
Company
Guangzhou Longest Science & Technology Co., Ltd.
Model
LGT-2500S, config II
Published
2020-10-15
Public version status
Update
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
06971410780261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971410780261069714107802616971410780261

GMDN Terms#

Term, Definition table
TermDefinition
Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy systemAn assembly of devices designed to provide electromechanical orthopaedic extracorporeal shock wave therapy (OEST) and pneumatic pressure wave therapy to treat musculoskeletal disorders. It is typically mobile and includes a control unit that uses both an electrical current and compressed air to create kinetic energy which is transferred to a patient's body upon contact (e.g., with two different hand-held surface applicators) 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
527141843
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
06971410780254Compression Therapy DeviceLGT-2201DVT2020-10-16
06971410780063Portable Electro-Stimulation Therapy DeviceLGT-2332021-12-02
06971410780032Portable Electro-Stimulation Therapy DeviceLGT-232(US)2020-11-06
06971410780025Portable Electro-Stimulation Therapy DeviceLGT-231(US)2020-10-30
06971410780049Portable Electro-Stimulation Therapy DeviceLGT-235(US)2019-11-03
06971410780278Radial Pressure Pulse Therapy DeviceLGT-2500S, config III2020-10-15
06971410780346Active Passive Trainer for Upper and Lower LimbsLGT-5100D2020-10-20
06971410780100Compression Therapy DeviceLGT-2200SP2019-11-03

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