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TensCare Shockwave

by Tenscare Limited

TensCare Shockwave (K-SHOCKWAVE) is a medical device (FDA Class I; FDA product code ISA, Massager, Therapeutic, Electric) made by Tenscare Limited, listed in FDA GUDID since 8 Jun 2023 (UDI-DI 05033435133796), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05033435133796 UDI-DI Date8 Jun 2023ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
TensCare
Generic name
Electromechanical orthopaedic extracorporeal shock wave therapy system
Model / Ref / Catalog
Shockwave, K-SHOCKWAVE
Primary DI / UDI-DI
05033435133796
FDA product code
ISA
GMDN term
Electromechanical orthopaedic extracorporeal shock wave therapy system
Device class
Class I
Regulation number
890.5660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electromechanical orthopaedic extracorporeal shock wave therapy system

Similar devices

Other devices filed under FDA product code ISA (Massager, Therapeutic, Electric).

Other devices from Tenscare Limited

See all devices from Tenscare Limited →

Properties

  • Over-the-counter
  • Premarket exempt
  • Serial number
Other properties (12, all answered No)