Transcutaneous Electronic Nerve Stimulator (KTR-2301 +11 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K242332

by Shenzhen Kentro Medical Electronics Co., Ltd

Identifiers

510(k) Number: K242332 FDA 510(k)
FDA Product Code: NUH FDA 510(k)
Models / Variants: KTR-2301 FDA 510(k)
KTR-2302 FDA 510(k)
KTR-2341 FDA 510(k)
KTR-2342 FDA 510(k)
KTR-2401 FDA 510(k)
KTR-2402 FDA 510(k)
KTR-2411 FDA 510(k)
KTR-2412 FDA 510(k)
KTR-2491 FDA 510(k)
KTR-2492 FDA 510(k)
KTR-2493 FDA 510(k)
KTR-2494 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)

Transcutaneous Electronic Nerve Stimulator (KTR-2301 +11 more) by Shenzhen Kentro Medical Electronics Co., Ltd — Class II — FDA_510K — listed in FDA 510(k)…

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	K242332	Class II	Active

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Manufacturer

Manufacturer: Shenzhen Kentro Medical Electronics Co., Ltd
FDA Applicant: Shenzhen Kentro Medical Electronics Co., Ltd.

Sources (1)

FDA 510(k) K242332 24 fields · synced Jun 18, 2026