FDA.report

PIEZOWAVE2

Primary DI
04055207063989
Brand
PIEZOWAVE2
Company
Richard Wolf GmbH
Model
100506
Catalog number
100506
Device description
PIEZOWAVE 2 CONTROL UNIT for all standard indications in orthopedic extracorporeal shockwave therapy (ESWT) and trigger point shockwave therapy (TPST) as well as for acoustic compression therapy, touch screen, color display, control by footswitch, U: 100-240VAC, 50/60Hz, Dim. (wxhxd) 405x226x450mm
Published
2022-02-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
ISAMassager, therapeutic, electric

Product Code Classifications

CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207063989PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207063989040552070639894055207063989

GMDN Terms

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.

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags

DUNS number
315304071
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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