Ergoline/PASSION PLUS 40/3 Turbo Power (Black), Soltron S-45 FLIRT+AC

GUDID EJKP100003195A0

JK-Products GmbH

Ultraviolet tanning device
Primary Device IDEJKP100003195A0
NIH Device Record Keyaa7390d2-97f4-4b9f-8ce2-2ced6ff890da
Commercial Distribution StatusIn Commercial Distribution
Brand NameErgoline/PASSION PLUS 40/3 Turbo Power (Black), Soltron S-45 FLIRT+AC
Version Model NumberJK 103 / 40-3 AC
Company DUNS316232073
Company NameJK-Products GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEJKP100003195A0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LEJBooth, Sun Tan

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

Devices Manufactured by JK-Products GmbH

EJKP100004042A0 - Ergoline Vitality Pure Light 3 (10 min)2024-03-07
EJKP100003952B0 - Revive2023-12-11
EJKP100003960B0 - Revive RVT302023-12-11
EJKP100003973A0 - Revive PRO IR2023-11-23
EJKP100003892A0 - VITALITY 46/3 PLT AC USA2023-06-08
EJKP100003946A0 - Ergoline/PASSION PLUS 40/3 Smart Performance2023-06-08
EJKP100003952A0 - Revive 7200 2023-06-08
EJKP100003960A0 - Revive RVT302023-05-08

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