Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Axis Medical & Rehabilitation - Fortress 3-in-1-Combo - Analgesic TENS system
ARTG entry for
Medical Device Included Class IIa
Axis Medical & Rehabilitation
PO Box 1947,BOWRAL, NSW, 2576
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.
Shenzhen Roundwhale Technology Co Ltd
202 2/F Building 27 Dafa Industrial Park Longxi
Longgang District, Shenzhen,
1. Fortress 3-in-1-Combo - Analgesic TENS system
Medical device system
35372 Analgesic TENS system
Intended to treat various muscular and joint conditions by a combination of TEN, EMS and Message
functions. The device is intended to relieve pain and discomfort when used correctly.
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Produced at 02.11.2019 at 05:38:36 AEDT
This is not an ARTG Certificate document.
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