Ergoline Sunrise 7200 Hybrid Light Technology Planet Fitness/Sound/Bluetooth/VS

GUDID EJKP100003605A0

JK-Products GmbH

Ultraviolet tanning device
Primary Device IDEJKP100003605A0
NIH Device Record Keyb3c6f4bd-2a3f-4a9e-9ae1-e7a3da80ec64
Commercial Distribution StatusIn Commercial Distribution
Brand NameErgoline Sunrise 7200 Hybrid Light Technology Planet Fitness/Sound/Bluetooth/VS
Version Model NumberJK 158 / 48-0 HT VS
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
HIBCCEJKP100003605A0 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-09
Device Publish Date2019-05-01

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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