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Low-Frequency Multi-function Physiotherapy Instrument - KTR-2211

FDA 510(k)

Class II (US FDA 510(k))

510(k) K191982

by Shenzhen Kentro Medical Electronics Co., Ltd

Identifiers

510(k) Number
K191982 FDA 510(k)
FDA Product Code
NUH FDA 510(k)
Models / Variants
Model: KTR-2230 FDA 510(k)
KTR-2220 FDA 510(k)
KTR-2210 FDA 510(k)
KTR-2231 FDA 510(k)
KTR-2221 FDA 510(k)
KTR-2211 FDA 510(k)
KTR-2232 FDA 510(k)
KTR-2222 FDA 510(k)
KTR-2212 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)

Low-Frequency Multi-function Physiotherapy Instrument - KTR-2211 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

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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) K191982 24 fields · synced Jun 18, 2026