HIGHERDOSE

GUDID 00850049532297

Shenzhen Kaiyan Medical Equipment Co,. Ltd

Musculoskeletal infrared phototherapy unit, wearable

• Primary Device ID: 00850049532297
• NIH Device Record Key: 7fd53f2d-ad79-406f-9626-1b2d1f19eb9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HIGHERDOSE
• Version Model Number: ZLD-75W
• Company DUNS: 543062382
• Company Name: Shenzhen Kaiyan Medical Equipment Co,. Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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
GS1	00850049532297 [Primary]

FDA Product Code

• ILY: Lamp, Infrared, Therapeutic Heating

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: 2024-01-31
• Device Publish Date: 2024-01-23

On-Brand Devices [HIGHERDOSE]

• 00860006793548: MK66-L
• 00850049532297: ZLD-75W
• 00850049532471: The HlGHERDOSE Red And Infrared Light Mask (Model: MK66-L) is an over the counter device that is
• 00850049532440: The HIGHERDOSE Red Light Hat is a home wearable light-emiting diode phototherapy device withprov