Identity
- Trade Name
- Sinrel FDA UDI
- Generic Name
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
- Device Name
- TENS & PMS Unit FDA UDI
- Model / Reference
- YF1503X FDA UDI
- Description
- TENS & PMS Unit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06978146200018 FDA UDI
- 510(k) Number
- K220005 FDA UDI
- FDA Product Code
- NUH FDA UDI
- GMDN Term
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5890 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Analgesic transcutaneous electrical nerve stimulation system
Sinrel by Shenzhen Sinrel Tech Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K220005 also covers:
- Sinrel — SHENZHEN SINREL TECH LTD
- Sinrel — SHENZHEN SINREL TECH LTD
- Sinrel — SHENZHEN SINREL TECH LTD
- Sinrel — SHENZHEN SINREL TECH LTD
- Sinrel — SHENZHEN SINREL TECH LTD
- Sinrel — SHENZHEN SINREL TECH LTD
- Sinrel — SHENZHEN SINREL TECH LTD
- Sinrel — SHENZHEN SINREL TECH LTD
- Sinrel — SHENZHEN SINREL TECH LTD
- Sinrel — SHENZHEN SINREL TECH LTD
- Sinrel — Shenzhen Yuehua Xinsen Technology Co., Ltd.
- Sinrel — Shenzhen Yuehua Xinsen Technology Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Sinrel Tech Ltd
Sources (1)
- FDA UDI ca74cee1-2bf8-4526-b248-dd3c4f90c13b 34 fields · synced May 30, 2026