FDA device listing
G3PRO,Theragun Elite,Theragun Prime Plus,Theragun Pro,Theragun PRO PLUS
FDA device listing 2041661254 · HEALTHCARE TECHNOLOGY INTERNATIONAL LTD.
Key facts
| Proprietary names | G3PRO,Theragun Elite,Theragun Prime Plus,Theragun Pro,Theragun PRO PLUS |
|---|---|
| Owner/operator | HEALTHCARE TECHNOLOGY INTERNATIONAL LTD. |
| Owner/operator number | 9058334 |
| Product codes | ISA |
| Device names | ISA - Massager, Therapeutic, Electric |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.5660 |
| Review panels | Physical Medicine |
| Registered establishments | DONGGUAN BAO KANG DIAN ZI KE JI LIMITED, HEALTHCARE TECHNOLOGY INTERNATIONAL LTD. |
| Establishment registrations | 3008959444, 3020978007 |
| FEI numbers | 3008959444, 3020978007 |
| Establishment operations | Contract Manufacturer, Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database