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TheraTouch SW1 SR15-APP

by Drive Devilbiss Healthcare United States GUDID

Product code ISA

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00092237626924 UDI-DIDate28 Apr 2025ListedStatusIn distribution

Coverage

1 jurisdiction

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  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls: none on record (FDA, checked 23 Oct 2026)

Specification

GUDID · synced 23 Oct 2026

Trade Name
TheraTouch SW1
Generic Name
Multidisciplinary extracorporeal shock wave therapy system, mobile
Model / Reference
SR15-APP
Primary DI / UDI-DI
00092237626924
FDA Product Code
ISA
GMDN Term
Multidisciplinary extracorporeal shock wave therapy system, mobile
Device Class
Class I
Regulation Number
890.5660
Commercial Distribution
In Commercial Distribution

Related devices

Category: Multidisciplinary extracorporeal shock wave therapy systemElectromechanical orthopaedic extracorporeal shock wave therapy system applicatorPneumatic orthopaedic extracorporeal shock wave therapy system applicator

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date
Other properties (11)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No

Sources (1)

  • FDA UDI 136ef0e5-ccc2-4f1d-b4af-ac7b465ef238 34 fields · synced 23 Oct 2026