Syrebo

Basic Information

• Brand Name: Syrebo
• Primary DI: 06973408900019
• Version / Model: SY-HR
• Catalog Number: BXB
• Company Name: Shanghai SiYi Intelligent Technology Co., Ltd.
• Labeler DUNS: 416757473
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-24
• Public Version: 1
• Public Version Date: 2021-06-01
• Public Version Status: New
• Public Device Record Key: 3288eaec-36bd-4599-ba16-1ff514d24ab7

Device Description

The product is suitable for patients with certain hand movement ability, which can improve the precise control ability of the hand through assisting the hand to realize different gestures and movements. In addition, it can be applied in various training modes such as passive training, mirror training, active training, resistance training, power-assisted training and voice control training, to stimulate and intervene patients' central and peripheral nerves, which is helpful to the recovery of hand movement function of patients.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BXB	Exerciser, Powered	Physical Medicine	890.5380	1

GMDN Terms

Code	Name	Definition	Implantable	Status
17137	Hand/wrist continuous passive motion exerciser	A mains electricity (AC-powered) device designed to continuously move the metacarpal/interphalangeal joints (e.g., flexion and extension) without patient assistance during continuous passive motion (CPM) exercise therapy usually following surgery or trauma to the joints. It typically consists of a motorized carriage with straps to hold and move the hand/wrist, and an electrical control unit for the healthcare professional to set the variable range of motion and motion speed; digital displays, manual/automated safety capabilities, and other features may also be included. CPM is believed to stimulate articular tissues and circulation of synovial fluid, and to reduce joint oedema.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06973408900019	GS1