TENS & PMS - SM9033

FDA 510(k)

Class II (US FDA 510(k))

510(k) K220283

by Hong Qiangxing (Shenzhen) Electronics Limited

Identifiers

510(k) Number: K220283 FDA 510(k)
FDA Product Code: NUH FDA 510(k)
Models / Variants: Model:SM9009 FDA 510(k)
SM9021 FDA 510(k)
SM9128H FDA 510(k)
SM9015 FDA 510(k)
SM9055 FDA 510(k)
SM9033 FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 882.5890 FDA 510(k)
Regulation Number: 882.5890 FDA 510(k)
Advisory Committee: Neurology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

TENS & PMS - SM9033 by Hong Qiangxing (Shenzhen) Electronics Limited — Class II — FDA_510K — listed in FDA 510(k) — 6 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	K220283	Class II	Active

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Manufacturer

Manufacturer: Hong Qiangxing (Shenzhen) Electronics Limited

Sources (1)

FDA 510(k) K220283 24 fields · synced Jun 18, 2026