Identity
- Trade Name
- SUNA FDA UDI
- Generic Name
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
- Model / Reference
- SM9187 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971712723102 FDA UDI
- 510(k) Number
- K190009 FDA UDI
- FDA Product Code
- NGX FDA UDINUH FDA UDI
- GMDN Term
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5850 FDA UDI882.5890 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
Yes
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Analgesic transcutaneous electrical nerve stimulation system
Suna 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
K190009 also covers:
- Caring Mill by Aura Serene — Aura Medical, LLC
- Cloudix — Hong Qiangxing (Shenzhen) Electronics Limited
- Cloudix — Hong Qiangxing (Shenzhen) Electronics Limited
- EPULSE — Hong Qiangxing (Shenzhen) Electronics Limited
- MASTOGO — Hong Qiangxing (Shenzhen) Electronics Limited
- MASTOGO — Hong Qiangxing (Shenzhen) Electronics Limited
- MASTOGO — Hong Qiangxing (Shenzhen) Electronics Limited
- Physiat — Hong Qiangxing (Shenzhen) Electronics Limited
- TOMMIE COPPER — Hong Qiangxing (Shenzhen) Electronics Limited
- eMP10 — Hong Qiangxing (Shenzhen) Electronics Limited
- mastogo — Hong Qiangxing (Shenzhen) Electronics Limited
- mastogo — 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 |
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Manufacturer
- Manufacturer
- Hong Qiangxing (Shenzhen) Electronics Limited
Sources (1)
- FDA UDI dd77244f-bb3b-42a8-b1ca-9aa14fa54bf1 33 fields · synced Jun 1, 2026