DEVICE: TheraTouch SW1 (00092237626924)

Device Identifier (DI) Information

TheraTouch SW1
SR15-APP
In Commercial Distribution

COMPASS HEALTH BRANDS CORP.
00092237626924
GS1

1
827221698 *Terms of Use
Shockwave SR 15mm Applicator, Steel Round
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
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?
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.
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.
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
ISA Massager, Therapeutic, Electric
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

136ef0e5-ccc2-4f1d-b4af-ac7b465ef238
May 06, 2025
1
April 28, 2025
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
800-376-7263
CustomerService@compasshealthbrands.com
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