FDA.reportPublic FDA data

Radial Pressure Pulse Therapy Device

Primary DI
06976927170048
Brand
Radial Pressure Pulse Therapy Device
Company
Guangzhou Pinzhi Medical Technology Co., LTD
Model
PZ-3202
Published
2023-12-20
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
06976927170048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06976927170048069769271700486976927170048

GMDN Terms#

Term, Definition table
TermDefinition
Pneumatic orthopaedic extracorporeal shock wave therapy systemAn assembly of devices designed to provide pneumatic orthopaedic extracorporeal shock wave therapy (OEST) to treat musculoskeletal disorders. It typically consists of a control unit that produces pneumatically-generated shock waves at selected impulse frequencies, and a hand-held surface applicator used to apply the energy to the site of pain. It is commonly used to treat disorders such as tendinopathies (e.g., rotator cuff, patellar, Achilles), soft tissue pain near bones, plantar fasciitis (heel pain), epicondylopathy (tennis elbow), shin splints, and muscle-related pain syndromes.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
707766926
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06976927170192Air wave pressure circulation massagerPZ-31082023-12-26
06976927170208Air wave pressure circulation massagerPZ-31222023-12-26
06976927170062Radial Pressure Pulse Therapy DevicePZ-32112023-12-21
06976927170079Radial Pressure Pulse Therapy DevicePZ-32122023-12-21
06976927170086Radial Pressure Pulse Therapy DevicePZ-3212M2023-12-21
06976927170093Radial Pressure Pulse Therapy DevicePZ-3214M2023-12-21
06976927170154Air wave pressure circulation massagerPZ-3106F2023-12-21
06976927170161Air wave pressure circulation massagerPZ-3104L2023-12-21
06976927170178Air wave pressure circulation massagerPZ-3106L2023-12-21
06976927170185Air wave pressure circulation massagerPZ-3108L2023-12-21
06976927170246Active Passive Trainer For Upper And Lower LimbsPZ-52042023-12-21
06976927170017Radial Pressure Pulse Therapy DevicePZ-32012023-12-20
06976927170024Radial Pressure Pulse Therapy DevicePZ-3201C2023-12-20
06976927170031Radial Pressure Pulse Therapy DevicePZ-3201P2023-12-20
06976927170055Radial Pressure Pulse Therapy DevicePZ-3202M2023-12-20
06976927170109Air wave pressure circulation massagerPZ-3103D2023-12-20
06976927170116Air wave pressure circulation massagerPZ-3105S2023-12-20
06976927170123Air wave pressure circulation massagerPZ-31042023-12-20
06976927170130Air wave pressure circulation massagerPZ-31062023-12-20
06976927170147Air wave pressure circulation massagerPZ-3104F2023-12-20

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