FDA Registration
Active
🇦🇺 Australia
Therabody Australia Pty. Ltd.
Reg #: 3023613474
·
FEI: 3023613474
·
Expires 2026
Products
6
Proprietary Names
20
Establishment Types
1
Classifications
6
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Registration Details
- Registration Name
- Therabody Australia Pty. Ltd.
- Registration Number
- 3023613474
- FEI Number
- 3023613474
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Waterman Business Centre, Suite 16, C307, Level 3
- City
- Ringwood Victoria
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K210938
Owner / Operator
- Firm Name
- Therabody, Inc.
- Operator Number
- 10054050
- Address
- 1640 S Sepulveda Blvd, Suite 300
- City
- Los Angeles
- State
- CA
- Postal Code
- 90025
- Country
- US
- Correspondent
- CJ Frederick, III
US Agent
- Business Name
- THERABODY, INC.
- Contact Name
- CJ Frederick, III
- Address
- 1640 S Sepulveda Blvd Ste 300
- City
- Los Angeles
- State
- CA
- ZIP
- 90025
- Country
- US
- [email protected]
- Phone
- 310 5708341
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2017-02-06 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2022-03-11 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2022-03-11 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2022-03-11 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2022-03-11 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2022-03-01 |
Proprietary Names
Theragun Prime Gen 6
Theragun Pro (All Generations)
Wave Roller
Theragun Mini (All Generations)
Theragun Prime (All Generations)
Theragun Elite (All Generations)
Wave Duo
RecoveryPulse
Wave Solo
RecoveryTherm Knee
Theragun Sense
TheraCup
Theragun PRO Plus
Theragun Prime Plus
RecoveryTherm Back
Theragun Sense Gen 2
Theragun Relief
Theragun Mini Plus
PowerDot PD-01M2 MuscleStimulator
PowerDot 2
Establishment Types
Export Device to the United States But Perform No Other Operation on Device