Summary for ARTG Entry:
Kogan Australia Pty Ltd - Stimulator, electrical, analgesic, peripheral nerve, transcutaneous
ARTG entry for
Medical Device Included Class IIa
Kogan Australia Pty Ltd
139 Gladstone St,South Melbourne, VIC, 3205
ARTG Start Date
Medical Device Class IIa
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
Famidoc Technology Co Ltd
No 212 Yilong Road Hexi Industrial Zone
Jinxia Changan Town Dongguan, Guangdong
1. Stimulator, electrical, analgesic, peripheral nerve, transcutaneous
Single Device Product
35372 Analgesic TENS system
The TENS & EMS Stimulator is a battery operated pulse generator that sends electrical impulses to the
body in order to reach the nerves and underlying muscle group. The device consists of an external
stimulator and electrodes placed on the skin. The device is intended to improve blood circulation and is to
be used for pain relief, muscle stimulation and massage. The device provides two controllable output
channels, each output channel has parameters controlled by buttons. The intensity level is adjustable
according to the needs of patients.
No Specific Conditions included on Record
© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior
written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.
Page 1 of
Produced at 09.11.2017 at 11:34:50 AEDT
This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
Visit www.tga.gov.au for contact information