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Elements Synergy JK 186 / 44-4 AC

by JK-Products GmbH

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberEJKP100004099 UDI-DI Date1 Oct 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Elements Synergy
Generic Name
Ultraviolet tanning device
Model / Reference
JK 186 / 44-4 AC
Primary DI / UDI-DI
EJKP100004099
510(k) Number
FDA Product Code
LEJ
GMDN Term
Ultraviolet tanning device
Device Class
Class II
Regulation Number
878.4635
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K220500)

Show all (12)

Other devices from JK-Products GmbH

See all devices from JK-Products GmbH →

Properties

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

Other properties (11)

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