Identity
- Trade Name
- NEOCARBON FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Model / Reference
- SM9910 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971712724185 FDA UDI06971712724536 FDA UDI06971712722341 FDA UDI06971712724802 FDA UDI
- 510(k) Number
- K121719 FDA UDI
- FDA Product Code
- GZJ 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 UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Category: Physical therapy transcutaneous neuromuscular electrical stimulation system
Neocarbon by Hong Qiangxing (Shenzhen) Electronics Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K121719 also covers:
- Pro Comfort TENS Unit — HOME AIDE DIAGNOSTICS, INC.
- Belifu — Hong Qiangxing (Shenzhen) Electronics Limited
- Belifu — Hong Qiangxing (Shenzhen) Electronics Limited
- Belifu — Hong Qiangxing (Shenzhen) Electronics Limited
- Belifu — Hong Qiangxing (Shenzhen) Electronics Limited
- Belifu — Hong Qiangxing (Shenzhen) Electronics Limited
- Belifu — Hong Qiangxing (Shenzhen) Electronics Limited
- Belifu — Hong Qiangxing (Shenzhen) Electronics Limited
- Belifu — Hong Qiangxing (Shenzhen) Electronics Limited
- Belifu — Hong Qiangxing (Shenzhen) Electronics Limited
- Belifu — Hong Qiangxing (Shenzhen) Electronics Limited
- CureChoice — Hong Qiangxing (Shenzhen) Electronics 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hong Qiangxing (Shenzhen) Electronics Limited
Sources (4)
- FDA UDI f03050cc-8e9f-45ec-ae5a-4d2d72412d4a 33 fields · synced Jun 8, 2026
- FDA UDI 0625ecb5-9bf6-4183-8aa9-35e371d5d6d2 33 fields · synced May 25, 2026
- FDA UDI 270a00c8-f61d-4d5e-83ad-5f33ba05f790 33 fields · synced May 26, 2026
- FDA UDI 3dd3227c-e531-4a6c-adf7-cac46d2023f4 33 fields · synced May 26, 2026