AccessGUDID - DEVICE: TheraTouch SW1 (00092237626962)

GUDID

Device Identifier (DI) Information

Brand Name: TheraTouch SW1
Version or Model: CR20-APP
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: COMPASS HEALTH BRANDS CORP.

Primary DI Number: 00092237626962
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 827221698 *Terms of Use

Device Description: Shockwave CR 20mm Applicator

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):	Yes
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?
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
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

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: No 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: aab5315f-46bc-4691-a0e6-b26d2f0dfe21
Public Version Date: April 14, 2025
Public Version Number: 1
DI Record Publish Date: April 04, 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
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 800-376-7263
Email: CustomerService@compasshealthbrands.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES