Ergolline Shine PLT

GUDID EJKP100003996A0

JK-Products GmbH

Ultraviolet tanning device

• Primary Device ID: EJKP100003996A0
• NIH Device Record Key: 545c2bdf-098c-4ad0-987f-3fd27a2af438
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ergolline Shine PLT
• Version Model Number: JK 191 / 32-0 PLT
• 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	EJKP100003996A0 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-08
• Device Publish Date: 2025-04-30

Devices Manufactured by JK-Products GmbH

• EJKP100003993A0 - Planet Fitness 40/3 HLT Plus: 2025-05-08
• EJKP100003996A0 - Ergolline Shine PLT: 2025-05-08
• EJKP100003996A0 - Ergolline Shine PLT: 2025-05-08
• EJKP100003999A0 - Ergoline Pulse PLT: 2025-05-08
• EJKP100004000A0 - Ergoline Spirit HLT: 2025-05-08
• EJKP100004001A0 - Ergoline Spirit PLT: 2025-05-08
• EJKP100004083A0 - Ergoline Spirit HLT: 2025-05-08
• EJKP100004084A0 - Ergoline Spirit PLT: 2025-05-08
• EJKP100004085A0 - Planet Fitness 40/3 HLT Plus: 2025-05-08