Data / Medical devices / Australia / Therabody Australia Pty. Ltd.
Therabody Australia Pty. Ltd.: FDA-registered device maker in Ringwood Victoria, Australia, 2 510(k) clearances
Therabody Australia Pty. Ltd. is registered with the FDA (registration 3023613474) in Ringwood Victoria, Australia. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 30, 2021. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3023613474
- Address
- Waterman Business Centre Suite 16, C307, Level 3, Ringwood Victoria, Australia, 3134
- Owner or operator
- Therabody, Inc. (10054050)
- Roles
- Exporter to the US
- First device listed
- March 1, 2022
- Registered through
- 2027
- Brand names listed
- PowerDot 2, PowerDot PD-01M2 MuscleStimulator
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cutaneous | GXY | 2 | Exporter to the US | accessdata.fda.gov |
| Stimulator, Muscle, Powered | IPF | 2 | Exporter to the US | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Exporter to the US | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | Exporter to the US | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 30, 2021 | K210938 | PowerDot PD-01MT2 Muscle Stimulator | IPF | Substantially Equivalent | Smartmissimo Technologies Pte, Ltd. | accessdata.fda.gov |
| December 13, 2017 | K171381 | Adhesive Electrodes | GXY | Substantially Equivalent | Shenzhen Quality Medical Technology Co.,Ltd | accessdata.fda.gov |
Compare with other makers
- All makers of Electrode, Cutaneous
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
- All makers of Stimulator, Nerve, Transcutaneous, Over-The-Counter
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
- All makers of Stimulator, Muscle, Powered
Updated July 30, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.