OmniCycle® Revo

General Description: The system is a therapeutic device for circular passive, assistive or active movement. The transition from motor-supported passive to active therapy is seamless. The…

Registry build 21.09.26

General Description: The system is a therapeutic device for circular passive, assistive or active movement. The transition from motor-supported passive to active therapy is seamless. The medical device can be used in a sitting position and the pivoting drive makes it easy to switch from lower extremity to upper extremity mode. The system can be used stationary or wheeled from room to room effortlessly. With the barrier free base frame and using the pivoting drive unit, the device can be individually positioned for each patient. The device can be quickly adapted to the patient through tool-free adjustments and various accessories. The software offers goal-oriented gamification, assessments and documentation to track therapy progress. The encased crank design ensures effective disinfection and safety. The system therefore facilitates safe, easy and efficient therapy for active persons as well as weak patients with particular needs. The equipment at the device ensure a stable, non-slip, and tilt-resistant position both during preparation and throughout the training session. Suitable devices guarantee a non-slip and tilt resistant stand during the training preparation of the device as well as during the training. The therapy drive unit moves the support devices for the legs (footrests) and arms (e.g. therapy grips) in a circular motion. The patient’s movement is controlled by the therapy drive unit and limited by the selected crank radius. Both the upper and lower extremities are trained by the same drive unit. The therapy drive unit never moves the arms and legs simultaneously. The interfaces for the arm and leg accessories are designed for easy attachment and exchange of specific options. This allows optimal securing of the patient according to their individual needs and degree of impairment. Additional description: OmniCycle® Revo with electrical height adjustment and mobility chassis.

27manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (6), Guangdong (6), Fujian (5). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code BXB
Manufacturer City Province Registered as Device types
Guangzhou Nuoning Medical Supplies Co., Ltd. Guangzhou Guangdong Contract manufacturer 62
IPE Plastic & Hardware Industy, Ltd Dongguan Guangdong Contract manufacturer 15
Ningbo Ningyuan Import & Export Co., Ltd. Ningbo Zhejiang Contract manufacturer 80
Saferlife Products Co., Ltd. Guangzhou Guangdong Contract manufacturer 58
Xiamen Ortocare Sports Health Co., Ltd. Xiamen Free Trade Zone Fujian Contract manufacturer 32
Jiangsu Rooe Medical Technology Co., Ltd. Zhangjiagang Jiangsu Manufacturer 31
Shenzhen Eyco Technology Co., Ltd. Shenzhen Guangdong Manufacturer 27
Xiamen J-Brace Medical Equipment Co., Ltd. Xiamen Fujian Repacker / relabeller 24
Hangzhou Zhongzhi Industry Co., Ltd. Hangzhou Zhejiang Manufacturer 22
Zhejiang Mateside Medical Devices Technology Co., Ltd. Ningbo Zhejiang Contract manufacturer 21
Anhui Kangfu Industrial Foreign Trade Co., Ltd. Tianchang Anhui Contract manufacturer 18
Fuzhou Feiwo Trading Co., Ltd. Fuzhou Fujian Manufacturer 11

Showing 12 of 27. All 27 manufacturers in China registered for Exerciser, Powered

Record

Regulatory record for OmniCycle® Revo
Listed by Medica Medizintechnik Gmbh, Germany
FDA product code BXB
Device type Exerciser, Powered
Device class Class 1
Regulation 21 CFR 890.5380
Establishment Manufacturer
Premarket notification Exempt
Record published 2025-12-16

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries serial number

Catalogue Numbers

Catalogue numbers for OmniCycle® Revo
Catalogue number Size Status
01.05.ZZ In distribution
01.05.ZZ In distribution

Same Product Code

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Showing 12 of 91. All products under Exerciser, Powered

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer