Rehabilitation Equipment Maker Promedi Signs the ISO 13485 and CE Mark Certification Agreement for Oversea Expansion

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Nov. 04, 2013 14:06

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WONJU--(Korea Newswire)--Medical device company Promedi (CEO Jong Cheol Park, www.stratek.co.kr) said it has signed an agreement with the Korea Institute of Medial Device Assessment (KIMDA) for the ISO 13485 and CE mark certification.

The agreement for ISO 13485 certification establishes the reference for various international certification standards that are compliated. Also, once the KIMDA’s project for supporting acquirement of international certification standards complete by next September, the company will be given the CE mark, which will allow the company to enter the European market.

The products affected by this agreement include Promedi’s motor limbs exerciser (MotorCross/MC-1, MC2, MC-3) and the motor orthopedic exerciser (CPM, CPS-3000/CPS-4000).

The motor limbs exerciser is a stationary exerciser used to rebuild muscles, recover articulation exercise, and to strengthen muscles.
The equipment can be operated with the motor or with the own strength of the users’ arms and legs. Speed, resistance, time, and direction can be adjusted.

The motor orthopedic exerciser uses continuous passive movement (CPM) to prevent the shoulder muscles from hardening and improves blood circulation in lesions. It reduces the time and effort put into rehabilittion as it evokes gradual improvement in the recovery organ and the joints from the early stage.

“We will develop products that meets the standards for ISO 13485 and CE mark certification to enhance Promedi’s league and to spur the overseas expansion,” said CEO Park.

Promedi Co.,Ltd.: http://www.stratek.co.kr