AccessGUDID - DEVICE: Syrebo (06973408900019)

GUDID

Device Identifier (DI) Information

Brand Name: Syrebo
Version or Model: SY-HR
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BXB
Company Name: Shanghai SiYi Intelligent Technology Co., Ltd.

Primary DI Number: 06973408900019
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 416757473 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
BXB	Exerciser, Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3288eaec-36bd-4599-ba16-1ff514d24ab7
Public Version Date: June 01, 2021
Public Version Number: 1
DI Record Publish Date: May 24, 2021