FDA device listing
Health Expert Electronic Stimulator-AST-300F, AST-300H, AST-300J
FDA device listing 1998589378 · Shenzhen OSTO Medical Technology Company Limited
Key facts
| Proprietary names | Health Expert Electronic Stimulator-AST-300F, AST-300H, AST-300J |
|---|---|
| Owner/operator | Shenzhen OSTO Medical Technology Company Limited |
| Owner/operator number | 10048304 |
| Premarket submissions | K190673 |
| Product codes | NGX, NUH |
| Device names | NGX - Stimulator, Muscle, Powered, For Muscle Conditioning, NUH - Stimulator, Nerve, Transcutaneous, Over-The-Counter |
| Device class | Class II |
| Classification regulations (21 CFR) | 882.5890, 890.5850 |
| Review panels | Neurology, Physical Medicine |
| Registered establishments | Shenzhen OSTO Medical Technology Company Limited |
| Establishment registrations | 3011564440 |
| FEI numbers | 3011564440 |
| Establishment operations | Complaint File Establishment, Foreign Private Label Distributor, Manufacturer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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