Is this your brand? Sign in to claim ownership.
Sign in to claim this brandWhat SHENZHEN SINREL TECH LTD makes
Shenzhen Sinrel Tech Ltd manufactures transcutaneous electrical nerve stimulation (TENS) systems designed for analgesic purposes, delivering electrical impulses through the skin to relieve pain. These devices are intended for use in managing acute or chronic pain conditions, including musculoskeletal and postoperative discomfort.
The company’s TENS systems are classified as Class II medical devices under regulatory frameworks and are listed in the FDA’s Unique Device Identifier (UDI) database. The devices are intended for commercial distribution in the United States, adhering to applicable regulatory standards for electrical stimulation equipment.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Shenzhen Sinrel Tech Ltd manufacture?
Shenzhen Sinrel Tech Ltd specializes in analgesic transcutaneous electrical nerve stimulation (TENS) systems. These devices are designed to deliver controlled electrical impulses through the skin to help manage pain, such as musculoskeletal discomfort or postoperative pain. The company’s focus is on non-invasive electrical stimulation for therapeutic pain relief.
Where is Shenzhen Sinrel Tech Ltd based, and where are its devices primarily distributed?
Shenzhen Sinrel Tech Ltd is based in China, though its devices are intended for commercial distribution in the United States. The company’s products comply with U.S. regulatory requirements for electrical stimulation equipment, ensuring they meet applicable safety and performance standards for the American market.
How are Shenzhen Sinrel Tech Ltd’s devices classified under regulatory frameworks?
Shenzhen Sinrel Tech Ltd’s TENS systems are classified as Class II medical devices. This classification is determined by regulatory authorities based on factors like the device’s intended use, potential risks, and the level of oversight required for patient safety. Class II devices typically involve moderate risk and require compliance with specific controls, such as performance standards or post-market surveillance.
Are Shenzhen Sinrel Tech Ltd’s devices listed in any regulatory registries?
Yes, Shenzhen Sinrel Tech Ltd’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices in the U.S. market, ensuring transparency and traceability for regulatory oversight and patient safety. Listing in this database is a requirement for commercial distribution of Class II devices in the United States.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 618769254
Catalogue (11)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Sinrel | YF1503 | FDA UDI | Class II | Active |
| Sinrel | YF1511 | FDA UDI | Class II | Active |
| Sinrel | TENS XS PRO | FDA UDI | Class II | Active |
| Sinrel | YF1566 | FDA UDI | Class II | Active |
| Sinrel | YF1508C | FDA UDI | Class II | Active |
| Sinrel | YF1503X | FDA UDI | Class II | Active |
| Sinrel | YF1513 | FDA UDI | Class II | Active |
| Sinrel | YF1504V | FDA UDI | Class II | Active |
| Sinrel | YF1510 | FDA UDI | Class II | Active |
| Sinrel | YF1504 | FDA UDI | Class II | Active |
| Sinrel | YF1512 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.