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Smart-RST SAWT-XXXX

by Hyperion Medical Technologies, Inc.

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850071298017 UDI-DI Date2 Jun 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Smart-RST
Generic Name
Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system
Model / Reference
SAWT-XXXX
Primary DI / UDI-DI
00850071298017
FDA Product Code
ISA
GMDN Term
Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system
Device Class
Class I
Regulation Number
890.5660
GUDID distribution status
In Commercial Distribution

Other devices from Hyperion Medical Technologies, Inc.

Properties

  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No