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Medical Devices & Health Equipment

CE/FDA-cleared Chinese medical equipment: ultrasound, patient monitors, ventilators, IVD analysers and rehabilitation robotics for hospitals and distributors.

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Medical Devices & Health Equipment ×Rehabilitation Robot ×Hospitals ×

Category

New Energy: EV, Solar & Energy Storage8
Consumer Electronics & Drones8
Industrial Machinery & Robotics8
Medical Devices & Health Equipment8
Home Appliances & Smart Home8
Building Materials, Hardware & Power Tools8

Product type

Ultrasound System2
Patient Monitor1
Rehabilitation Robot1
CT Scanner1
IVD Analyser1
PET/CT Scanner1
Oxygen Concentrator1

Media & data

Application video available7
High-confidence data only6

Certification

EU MDR Quality Management System certificate (TUV SUD, cert. no. G10 091264 0025 Rev. 01) covering Class IIb Vital Signs Monitoring Instruments - not a model-specific iM80 product certificate1
Documented as compliant with IEC/EN 60601-1, 60601-2-27, -2-30, -2-34, -2-49, -2-25 and -2-51, ANSI/AAMI EC13 and ANSI/AAMI SP10 in Edan's published specification1
CE MDR (EU) reported at Fourier rehabilitation-robot portfolio level, June 2024 (TUV SUD via the Microkn announcement); no per-model certificate or FDA clearance was found for the ExoMotus M4.1
FDA 510(k) K253049, cleared 11 February 2026 (Class II; 21 CFR 892.1550 / 892.1560 / 892.1570; product codes IYN, IYO, ITX)1
NMPA Class III registration 国械注准20203060462 (valid to 2030-05-07). No FDA 510(k) or model-specific CE certificate was found for the NeuViz Epoch, so neither is claimed.1
FDA 510(k) K170264 - Gold AQ Blood Glucose Monitoring System platform clearance (Changsha Sinocare, Inc., 2017); Plus-specific 510(k) coverage was not separately confirmed1
EN ISO 15197:2015 (per official Sinocare product page)1
FDA 510(k) K172082 - S60 Series (cleared 21 September 2017)1
FDA 510(k) K201059 - S60 Elite Series / S70 Series (cleared 30 July 2020)1
FDA 510(k) K241585, cleared 30 August 2024 (product code KPS)1

Application industry

Hospitals8
Diagnostic imaging centres4
Clinics3
OB/GYN and women's health clinics2
Home healthcare2
Intensive care units1
Operating rooms1
Emergency departments1
Cardiology1
Rehabilitation centres1

Manufacturer

Edan Instruments, Inc.1
Fourier Intelligence (Fourier Rehab)1
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.1
Neusoft Medical Systems Co., Ltd.1
Sinocare Inc.1
SonoScape Medical Corp.1
Shanghai United Imaging Healthcare Co., Ltd.1
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.1

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Fourier ExoMotus M4 Lower-Limb Rehabilitation Exoskeleton

Video Medical Devices & Health Equipment

Fourier Intelligence (Fourier Rehab)

Fourier ExoMotus M4 Lower-Limb Rehabilitation Exoskeleton

Robotic lower-limb exoskeleton for early standing and gait rehabilitation

Rehabilitation Robot
CE MDR (EU) reported at Fourier rehabilitation-robot portfolio level, June 2024 (TUV SUD via the Microkn announcement); no per-model certificate or FDA clearance was found for the ExoMotus M4.

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Product data is compiled from publicly available manufacturer information and verified on the date shown on each product page. Specifications may change — always confirm with the manufacturer before ordering.