FDA.reportPublic FDA data

Radial Pressure Pulse Therapy Device

Primary DI
06976287180466
Brand
Radial Pressure Pulse Therapy Device
Company
Guangzhou Longest Medical Technology Co., Ltd.
Model
LGT-2500X
Published
2024-07-18
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
06976287180466PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06976287180466069762871804666976287180466

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
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
06976287180886Focused Shock Wave Therapy DeviceLGT-2520AP2024-07-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16973368290059MedisanaZhangzhou Easepal Medical Science And Technology Co., Ltd.ISA2026-04-30
07630039101855MASTERPULS®Storz Medical AGISA2026-04-15
00045915831424Human TouchHuman Touch, LLCISA2026-01-12
00045915831431Human TouchHuman Touch, LLCISA2026-01-12
00045915831448Human TouchHuman Touch, LLCISA2026-01-12
00045915831455Human TouchHuman Touch, LLCISA2026-01-12
00045915831462Human TouchHuman Touch, LLCISA2026-01-12
00045915831479Human TouchHuman Touch, LLCISA2026-01-12
00045915831486Human TouchHuman Touch, LLCISA2026-01-12
00045915831493Human TouchHuman Touch, LLCISA2026-01-12
08034108512679Plus HandpieceDEKA M.E.L.A. SRLISA2025-10-22
00197344153605MEDLINEMEDLINE INDUSTRIES, INC.ISA2025-10-17
08800205600003NeuclareDeepsonbio Co., LtdISA2025-08-08
08809643652087CERAGEM Master V9CERAGEM Co., Ltd.ISA2025-07-15
00810140061355RENPHOJoicom CorporationISA2024-11-19
00810140061362RENPHOJoicom CorporationISA2024-11-19
00810140061379RENPHOJoicom CorporationISA2024-11-19
00810140061386RENPHOJoicom CorporationISA2024-11-19
00810140061393RENPHOJoicom CorporationISA2024-11-19
00810140061409RENPHOJoicom CorporationISA2024-11-19
00810140061416RENPHOJoicom CorporationISA2024-11-19
00810140061447RENPHOJoicom CorporationISA2024-11-19
00810140061690RENPHOJoicom CorporationISA2024-11-19
00810140061706RENPHOJoicom CorporationISA2024-11-19
00810140061768RENPHOJoicom CorporationISA2024-11-19
00810140061782RENPHOJoicom CorporationISA2024-11-19
00810140061799RENPHOJoicom CorporationISA2024-11-19
00810140061805RENPHOJoicom CorporationISA2024-11-19
00810140061812RENPHOJoicom CorporationISA2024-11-19
00810140061829RENPHOJoicom CorporationISA2024-11-19