Relax

GUDID 04716171749018

Far Infrared Ray Healthful Lamp (or Medical FIR Radiator)

CHUNG CHENG ELECTRIC HEATING CO., LTD.

Musculoskeletal infrared phototherapy unit, non-wearable

• Primary Device ID: 04716171749018
• NIH Device Record Key: 1e015727-d0a2-4f0a-9849-68da141816b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Relax
• Version Model Number: CH-8810
• Company DUNS: 657028122
• Company Name: CHUNG CHENG ELECTRIC HEATING CO., LTD.
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04716171749018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053376

FDA Product Code

• ILY: Lamp, Infrared, Therapeutic Heating

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-09