This facility is provided to enable any interested parties to search for Registered Medical Device, Registered CAB, Licensed Establishments under Section 5, 10, 15 of Medical Device Act 2012 (Act 737) respectively and Notified Medical Device under Medical Device (Exemption) Order 2016. Any party who wishes to know whether an establishment who is dealing with medical device has been licensed under Act 737 may search the establishment by inserting the establishment name or license number in the searching field below.


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DEVICE DETAILS

NAME OF DEVICEWIRELESS TENS UNIT
ESTABLISHMENT NAMETECHCARE INNOVATION SDN BHD
ROLE OF ESTABLISHMENTMANUFACTURER
REGISTRATION NOGB9204323-144464
BRAND NAMEKTR-2493
MEDICAL DEVICE CATEGORYMD 1108 - Active rehabilitation devices and active prostheses
DEVICE GROUPING TYPESYSTEM
DEVICE DESCRIPTIONThe device works on the basis of electrical nerve stimulation (TENS) or transcutaneous electrical nerve stimulation, relates to the electrical stimulation of the nerves through the skin.
DEVICE INTENDED PURPOSETo be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg and foot, due to strain from exercise or normal household and work activities.
VALIDITY DATE OF REGISTRATION11/08/2023 - 10/08/2028

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Wireless TENS UnitKTR-2493
2Electrode padEPAD-H01
3Electrode padEPAD-H02
4Electrode padEPAD-F01
5Electrode padEPAD-F02
6Electrode padEPAD-F03
7Electrode padEPAD-B01
8Electrode padEPAD-T01
9Electrode padEPAD-Z01
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