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Passive and active rehabilitation training device for upper and lower limbs - NMPA Registration 豫械注准20242190687

Access comprehensive regulatory information for Passive and active rehabilitation training device for upper and lower limbs in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 豫械注准20242190687 and owned by XiangyuMedicalCo.,Ltd.. The device was approved on August 27, 2024.

This page provides complete registration details including registrant information, province location (Henan), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.

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Class II
豫械注准20242190687
Passive and active rehabilitation training device for upper and lower limbs
上下肢主被动康复训练仪
NMPA Registration Number: 豫械注准20242190687
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Pricing
Intended Use
English

This product is intended for use by operators with relevant expertise in healthcare facilities. XY-ZBD-IDL type is suitable for improving the muscle strength of the upper limbs, maintaining the range of motion of the joints of the upper limbs, improving the motor function of the upper limbs of patients with hemiplegia caused by stroke, and promoting the recovery of upper limb motor function of patients with hemiplegia caused by stroke. XY-ZBD-IIDL is suitable for improving the muscle strength of the lower limbs, maintaining the range of motion of the joints of the lower limbs, improving the motor function of the lower limbs in patients with hemiplegia caused by stroke, and promoting the recovery of lower limb motor function in patients with hemiplegia caused by stroke. XY-ZBD-IIIDL and XY-ZBD-IIIDH are suitable for improving the muscle strength of the upper and lower limbs, maintaining the range of motion of the upper and lower limbs, improving the motor function of the upper and lower limbs of patients with hemiplegia caused by stroke, and promoting the recovery of upper and lower limb motor function of patients with hemiplegia caused by stroke.

中文

本产品供医疗机构中具备相关专业知识的操作者使用。XY-ZBD-IDL型适用于改善患者上肢肌力,维持上肢关节活动度,改善脑卒中导致偏瘫的患者上肢运动功能,促进脑卒中导致偏瘫的患者上肢运动功能恢复。XY-ZBD-IIDL型适用于改善患者下肢肌力,维持下肢关节活动度,改善脑卒中导致偏瘫的患者下肢运动功能,促进脑卒中导致偏瘫的患者下肢运动功能恢复。XY-ZBD-IIIDL型和XY-ZBD-IIIDH型适用于改善患者上下肢肌力,维持上下肢关节活动度,改善脑卒中导致偏瘫的患者上下肢运动功能,促进脑卒中导致偏瘫的患者上下肢运动功能恢复。

Device Classification
Device Class
Class II
Model Specifications
XY-ZBD-IDL、XY-ZBD-IIDL、XY-ZBD-IIIDL、XY-ZBD-IIIDH
Approval Department
Henan Provincial Drug Administration
河南省药品监督管理局
Registration Information
Registration Number
豫械注准20242190687
Approval Date
August 27, 2024
Expiry Date
August 26, 2029
Registrant
Name
XiangyuMedicalCo.,Ltd.
河南翔宇医疗设备股份有限公司
Province/Region
Henan
河南
Address
The middle section of Di Zhe Avenue in Huang County, Anyang City, Henan Province
河南省安阳市内黄县帝喾大道中段
Production Facility
Production Address
河南省安阳市内黄县帝喾大道中段
Structure and Composition
English

XY-ZBD-IDL is composed of a main unit, a handle, an upper limb training part, an emergency stop button, a pole, and a caster. XY-ZBD-IIDL is composed of a main machine, a lower limb training part, a fixed leg board, a foot pedal, an emergency stop button, a pole, and a caster. XY-ZBD-IIIDL is composed of a main unit, a handle, an upper limb training part, a lower limb training part, a fixed leg board, a foot pedal, an emergency stop button, a pole, and a caster. XY-ZBD-IIIDH is composed of a host, a handle, an upper limb training part, a lower limb training part, a fixed leg board, a foot pedal, an emergency stop button, a pole, a caster, and an electrical stimulation module.

中文

XY-ZBD-IDL由主机、手柄、上肢训练部分、急停按钮、立杆、脚轮组成。XY-ZBD-IIDL由主机、下肢训练部分、固定腿板、脚踏板、急停按钮、立杆、脚轮组成。XY-ZBD-IIIDL由主机、手柄、上肢训练部分、下肢训练部分、固定腿板、脚踏板、急停按钮、立杆、脚轮组成。XY-ZBD-IIIDH由主机、手柄、上肢训练部分、下肢训练部分、固定腿板、脚踏板、急停按钮、立杆、脚轮、电刺激模块组成。

Additional Information
Appendix
产品技术要求