FDA.reportPublic FDA data

TheraTouch SW1

Primary DI
00092237626931
Brand
TheraTouch SW1
Company
Drive Devilbiss Healthcare
Model
SR20-APP
Device description
Shockwave SR 20mm Applicator, Steel Round
Published
2025-04-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ISAMassager, Therapeutic, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00092237626931PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00092237626931000922376269310922376269310092237626931

GMDN Terms#

Term, Definition table
TermDefinition
Multidisciplinary extracorporeal shock wave therapy systemAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-376-7263CustomerService@compasshealthbrands.com

Regulatory Flags#

DUNS number
867673159
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00023601061102Carex Health BrandsFGR11000 00002016-10-07
00092237614419Roscoe MedicalHUM-ROS62018-12-19
50050428250391DRIVEMEDICAL7417372019-06-21
00311917192352Walgreens9847282019-06-21
00822383989815DRIVEMEDICAL146-RTLPC23201-M2019-06-21
00822383989839DRIVEMEDICAL146-RTLPC23201-F2019-06-21
00822383246420DriveRTLPC23201-F2017-05-19
00822383037127Silver SportBIN-SSP316DDA-SF2026-06-22
00822383037134Silver SportBIN-SSP218DDA-SF2026-06-22
00822383037141Silver SportBIN-SSP220DDA-SF2026-06-22
00822383037158Cruiser 3 16"BIN-K316ADDA-SF2026-06-22
00822383037165Cruiser 3 18"BIN-K318ADDA-SF2026-06-22
00822383037172Cruiser 3 20"BIN-K320ADDA-SF2026-06-22
00194346283439EquateEQKW5002026-06-10
10092237600105Roscoe MedicalEP4070WCD2016-10-18
90002360125501AccuReliefACRL-55002016-10-12
00009223761699Reliable MedicalEF2020BC2-TU2018-06-13
00009223761941EswallowESW-90502016-12-31
00023601005144CAREX HEALTH BRANDSFGA51400 00002022-12-20
00023601005151CAREX HEALTH BRANDSFGA51500 BLUE2022-12-20

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00045915831455Human TouchHuman Touch, LLCISA2026-01-12
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00045915831486Human TouchHuman Touch, LLCISA2026-01-12
00045915831493Human TouchHuman Touch, LLCISA2026-01-12
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