Identity
- Trade Name
- Electronic Stimulator FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of neck, arm, and leg, due to strain from exercise or normal household and work activities. Note1: The electrode on the stimulator is used in the waist. Note2: The additional gel patch is used in shoulder, waist, back, back of neck, arm, and leg. Heating: To be used for temporary relief of minor aches and pains. FDA UDI
- Model / Reference
- LQ-9525B FDA UDI
- Description
- To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of neck, arm, and leg, due to strain from exercise or normal household and work activities. Note1: The electrode on the stimulator is used in the waist. Note2: The additional gel patch is used in shoulder, waist, back, back of neck, arm, and leg. Heating: To be used for temporary relief of minor aches and pains. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974700021129 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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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 b861ff37-a383-405e-ae77-9b46d4331333 34 fields · synced May 29, 2026