HIGHERDOSE

Basic Information

• Brand Name: HIGHERDOSE
• Primary DI: 00850049532297
• Version / Model: ZLD-75W
• Company Name: Shenzhen Kaiyan Medical Equipment Co,. Ltd
• Labeler DUNS: 543062382
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-23
• Public Version: 1
• Public Version Date: 2024-01-31
• Public Version Status: New
• Public Device Record Key: 7fd53f2d-ad79-406f-9626-1b2d1f19eb9b

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	890.5500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63381	Musculoskeletal infrared phototherapy unit, wearable	A patient-worn, battery-powered device assembly intended to provide a source of infrared (IR) heat for localized treatment of musculoskeletal pain/injury (e.g., joint pain), and to improve blood circulation in these areas. It consists of a device with an integrated light with a controller; the light is intended to be attached to a specific body part (e.g., back, knee) and may include devices (e.g., adhesive pad) to allow attachment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850049532297	GS1