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Pain Therapy Device - DH-P.T.S-IIA
FDA 510(k)Class II (US FDA 510(k))
510(k) K212948
Identifiers
- 510(k) Number
- K212948 FDA 510(k)
- FDA Product Code
- NGX FDA 510(k)
- Models / Variants
- Model: DH-P.T.S-I FDA 510(k)DH-P.T.S-II FDA 510(k)DH-P.T.S-IIA FDA 510(k)DH-P.T.S-IIB FDA 510(k)DH-CP-I FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5850 FDA 510(k)
- Regulation Number
- 890.5850 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Pain Therapy Device - DH-P.T.S-IIA by Guangzhou Xinbo Electronic Co., Ltd — Class II — FDA_510K — listed in FDA 510(k) — 5 models — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212948 | Class II | Active |
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Manufacturer
- Manufacturer
- Guangzhou Xinbo Electronic Co., Ltd
- FDA Applicant
- Guangzhou Xinbo Electronic Co., Ltd.
Sources (1)
- FDA 510(k) K212948 24 fields · synced Jun 18, 2026