528i

Basic Information

• Brand Name: 528i
• Primary DI: G6815B11000
• Version / Model: 5i Series Rechargeable Battery
• Catalog Number: 5B1100
• Company Name: 528 Innovations LLC
• Labeler DUNS: 849568154
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-01
• Public Version: 1
• Public Version Date: 2025-03-10
• Public Version Status: New
• Public Device Record Key: 0de043f0-5b94-4300-831a-da026d9f1f62

Device Description

5i Series Rechargeable battery

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: No
• Has Manufacturing Date: No
• 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
60410	Musculoskeletal/physical therapy laser, home-use	An electrically-powered diode laser intended to provide noninvasive laser therapy [e.g., infrared phototherapy, low-level laser therapy (LLLT)] for localized treatment of musculoskeletal conditions (e.g., muscle pain, sports injury, rheumatism, disorders of the joints and soft/connective tissues), improvement of local blood/lymph circulation to facilitate healing/reduce swelling (e.g., lymphoedema therapy), or for non-needle acupuncture. It typically consists of a hand-held applicator designed for transcutaneous delivery of visible red/infrared laser light energy. It is intended to be operated by a patient/layperson in the home, typically under healthcare professional guidance.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G6815B11000	HIBCC

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 700 – 1060 millibar
• Type: Storage Environment Temperature
• Temperature Range: -20 – 30 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 15 – 90 Percent (%) Relative Humidity