AccessGUDID - DEVICE: PIEZOWAVE2 (04055207063989)

GUDID

Device Identifier (DI) Information

Brand Name: PIEZOWAVE2
Version or Model: 100506
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 100506
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207063989
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47790	Electromechanical orthopaedic extracorporeal shock wave therapy system	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ISA	Massager, therapeutic, electric

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cc0bd70f-6c99-43ce-ac06-8e495c266c1c
Public Version Date: February 22, 2022
Public Version Number: 1
DI Record Publish Date: February 14, 2022