DEVICE: TheraTouch SW1 (00092237626924)
Device Identifier (DI) Information
TheraTouch SW1
SR15-APP
In Commercial Distribution
COMPASS HEALTH BRANDS CORP.
SR15-APP
In Commercial Distribution
COMPASS HEALTH BRANDS CORP.
Shockwave SR 15mm Applicator, Steel Round
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
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Yes | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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67122 | Multidisciplinary extracorporeal shock wave therapy system |
An electrically-powered assembly of devices designed to provide noninvasive spark-gap-generated (electrohydraulic) extracorporeal shock wave therapy [ESWT] to treat a variety of conditions (e.g., tendinopathy, plantar fasciitis, acute wounds, pelvic pain) across a range of clinical disciplines [e.g., orthopaedics, dermatology, urology]. It typically consists of a generator/control unit, a foot-switch, and a hand-held applicator designed for transcutaneous transmission of acoustic shock waves to the target area. The applied energy is intended to stimulate the body's natural healing processes.
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Active | false |
47033 | Pneumatic orthopaedic extracorporeal shock wave therapy system applicator |
A hand-held device designed to apply pneumatic energy, from an orthopaedic extracorporeal shock wave therapy (OEST) system or a system control unit, to the site of a musculoskeletal disorder (usually pain) for the production of shock waves for treatment. It typically includes a flexible conduit that plugs into the control unit, and has a head portion that is moved over the surface of the body area to be treated. It is available in various sizes to treat different musculoskeletal disorders. This is a reusable device.
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Active | false |
47791 | Electromechanical orthopaedic extracorporeal shock wave therapy system applicator |
A hand-held device designed to transfer kinetic energy to a site on the body to create mechanical shock waves, at selected amplitudes and frequencies, to treat musculoskeletal disorders. It typically includes a conduit that plugs into an electrical control unit where the energy is generated, and has a head portion that is moved over the surface of the treatment area. It is available in various sizes or has exchangeable tips to treat different musculoskeletal disorders. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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ISA | Massager, Therapeutic, Electric |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
136ef0e5-ccc2-4f1d-b4af-ac7b465ef238
May 06, 2025
1
April 28, 2025
May 06, 2025
1
April 28, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-376-7263
CustomerService@compasshealthbrands.com
CustomerService@compasshealthbrands.com