FDA device listing
OMS01.OMS02,OMS03,OMS05,OMS06,OMS07,OMS08,,SHOCK VITALIZE AXIS,SHOCK VITALIZE NOVA,SHOCK VITALIZE EVO,SHOCK VITALIZE…
FDA device listing 1053816488 · Omedic Technology (Dongguan) Co., Ltd
Key facts
| Proprietary names | OMS01.OMS02,OMS03,OMS05,OMS06,OMS07,OMS08,,SHOCK VITALIZE AXIS,SHOCK VITALIZE NOVA,SHOCK VITALIZE EVO,SHOCK VITALIZE CURA,SHOCK VITALIZE NEO ONE,SHOCK VITALIZE CORE,SHOCK VITALIZE PRIME,ShockVitalize Mega,ShockVitalize Plus,ShockVitalize Cube,SHOCK VITALIZE LITE,SHOCK VITALIZE FOCUS,SHOCK VITALIZE OPTIMA,shockwave |
|---|---|
| Owner/operator | Omedic Technology (Dongguan) Co., Ltd |
| Owner/operator number | 10084669 |
| 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 | OMEDIC TECHNOLOGY (DONGGUAN) CO., LTD |
| Establishment registrations | 3022553912 |
| FEI numbers | 3022553912 |
| Establishment operations | Foreign Exporter, Manufacturer |
| 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