Identity
- Trade Name
- Electronic Stimulator FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the back of neck, due to strain from exercise or normal household and work activities. Heating: To be used for temporary relief of minor aches and pains. FDA UDI
- Model / Reference
- uNeck-9512A FDA UDI
- Description
- Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the back of neck, due to strain from exercise or normal household and work activities. Heating: To be used for temporary relief of minor aches and pains. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974700021006 FDA UDI
- 510(k) Number
- K223428 FDA UDI
- FDA Product Code
- NUH FDA UDIIRT FDA UDI
- GMDN Term
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5890 FDA UDI890.5740 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Physical therapy transcutaneous neuromuscular electrical stimulation system
Electronic Stimulator by Shenzhen Leqing Medical Instrument Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Physical therapy transcutaneous neuromuscular electrical stimulation system.
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Cleared under the same submission
K223428 also covers:
- Electronic Stimulator — Shenzhen Leqing Medical Instrument Co., Ltd.
- Electronic Stimulator — Shenzhen Leqing Medical Instrument Co., Ltd.
- Electronic Stimulator — Shenzhen Leqing Medical Instrument Co., Ltd.
- Electronic Stimulator — Shenzhen Leqing Medical Instrument Co., Ltd.
- Electronic Stimulator — Shenzhen Leqing Medical Instrument Co., Ltd.
- Electronic Stimulator — Shenzhen Leqing Medical Instrument Co., Ltd.
- Electronic Stimulator — Shenzhen Leqing Medical Instrument Co., Ltd.
- Electronic Stimulator — Shenzhen Leqing Medical Instrument Co., Ltd.
- Electronic Stimulator — Shenzhen Leqing Medical Instrument Co., Ltd.
- Electronic Stimulator — Shenzhen Leqing Medical Instrument Co., Ltd.
- Electronic Stimulator — Shenzhen Leqing Medical Instrument Co., Ltd.
- Electronic Stimulator — Shenzhen Leqing Medical Instrument 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 |
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Manufacturer
- Manufacturer
- Shenzhen Leqing Medical Instrument Co., Ltd.
Sources (1)
- FDA UDI 5d822a5d-8685-4471-a3bd-e63b399b083c 34 fields · synced May 31, 2026