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

GUDID EJKP100003195A0

JK-Products GmbH

Ultraviolet tanning device

• Primary Device ID: EJKP100003195A0
• NIH Device Record Key: aa7390d2-97f4-4b9f-8ce2-2ced6ff890da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ergoline/PASSION PLUS 40/3 Turbo Power (Black), Soltron S-45 FLIRT+AC
• Version Model Number: JK 103 / 40-3 AC
• Company DUNS: 316232073
• Company Name: JK-Products GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EJKP100003195A0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151400

FDA Product Code

• LEJ: Booth, Sun Tan

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by JK-Products GmbH

• EJKP100004042A0 - Ergoline Vitality Pure Light 3 (10 min): 2024-03-07
• EJKP100003952B0 - Revive: 2023-12-11
• EJKP100003960B0 - Revive RVT30: 2023-12-11
• EJKP100003973A0 - Revive PRO IR: 2023-11-23
• EJKP100003892A0 - VITALITY 46/3 PLT AC USA: 2023-06-08
• EJKP100003946A0 - Ergoline/PASSION PLUS 40/3 Smart Performance: 2023-06-08
• EJKP100003952A0 - Revive 7200: 2023-06-08
• EJKP100003960A0 - Revive RVT30: 2023-05-08