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Transcutaneous Electrical Nerve Stimulator (K6133 +12 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K250784

by Shenzhen Yicai Health Technology Co., Ltd.

Identifiers

510(k) Number
K250784 FDA 510(k)
FDA Product Code
NUH FDA 510(k)
Models / Variants
K6133 FDA 510(k)
K6134 FDA 510(k)
K6135 FDA 510(k)
K6136 FDA 510(k)
K6137 FDA 510(k)
K6138 FDA 510(k)
K6139 FDA 510(k)
K6140 FDA 510(k)
K6141 FDA 510(k)
K6142 FDA 510(k)
K6143 FDA 510(k)
K6144 FDA 510(k)
K6122 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 Electrical Nerve Stimulator (K6133 +12 more) by Shenzhen Yicai Health Technology Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 13…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhen Yicai Health Technology Co., Ltd.

Sources (1)

  • FDA 510(k) K250784 24 fields · synced Jun 18, 2026