Identity
- Trade Name
- Low-Frequency Therapy Instrument FDA UDI
- Generic Name
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
- Model / Reference
- KTR-206 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06924607700696 FDA UDI
- 510(k) Number
- K170205 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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Analgesic transcutaneous electrical nerve stimulation system
Low-Frequency Therapy Instrument by Shenzhen Kentro Medical Electronics Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K170205 also covers:
- Sensiv — Acutens Inc
- Bella Russo — NUVOMED INC
- NuvoMed — NUVOMED INC
- Low-Frequency Therapy Instrument — Shenzhen Kentro Medical Electronics Co., Ltd
- Low-Frequency Therapy Instrument — Shenzhen Kentro Medical Electronics Co., Ltd
- Low-Frequency Therapy Instrument — Shenzhen Kentro Medical Electronics Co., Ltd
- Low-Frequency Therapy Instrument — Shenzhen NearbyExpress Technology Development Company Limited
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 Kentro Medical Electronics Co., Ltd
Sources (1)
- FDA UDI 433a7a2b-fbf5-49ae-b32e-59e2fd06b362 33 fields · synced Jun 8, 2026