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Wellsystem Hydrowave Pure

by JK-Products GmbH

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 NumberEJKP100004182A0 UDI-DI Date30 Oct 2025ListedStatusListed 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  • Withdrawn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
Wellsystem
Generic Name
Hydrotherapy bath/tank
Model / Reference
Hydrowave Pure
Primary DI / UDI-DI
EJKP100004182A0
FDA Product Code
ISA
GMDN Term
Hydrotherapy bath/tank
Device Class
Class I
Regulation Number
890.5660
GUDID distribution status
In Commercial Distribution

Other devices from JK-Products GmbH

See all devices from JK-Products GmbH →

Properties

  • Over-the-Counter
  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (10)

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