Identity
- Trade Name
- No FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Model / Reference
- AS8016 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973810850162 FDA UDI
- 510(k) Number
- K202866 FDA UDI
- FDA Product Code
- NGX FDA UDI
- GMDN Term
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5850 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Physical therapy transcutaneous neuromuscular electrical stimulation system
No by Shenzhen Jian Feng Electronic Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K202866 also covers:
- No — Shenzhen Jian Feng Electronic Technology Co., Ltd.
- No — Shenzhen Jian Feng Electronic Technology Co., Ltd.
- No — Shenzhen Jian Feng Electronic Technology Co., Ltd.
- No — Shenzhen Jian Feng Electronic Technology Co., Ltd.
- No — Shenzhen Jian Feng Electronic Technology Co., Ltd.
- No — Shenzhen Jian Feng Electronic Technology Co., Ltd.
- No — Shenzhen Jian Feng Electronic Technology Co., Ltd.
- No — Shenzhen Jian Feng Electronic Technology Co., Ltd.
- No — Shenzhen Jian Feng Electronic Technology Co., Ltd.
- No — Shenzhen Jian Feng Electronic Technology Co., Ltd.
- No — Shenzhen Jian Feng Electronic Technology Co., Ltd.
- No — Shenzhen Jian Feng Electronic 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 Jian Feng Electronic Technology Co., Ltd.
Sources (1)
- FDA UDI e317ef2f-91fe-4b0e-bf97-924f077f547d 34 fields · synced May 30, 2026