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S Series Electrodes / (S55105 +11 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K173186

by Everyway Medical Instruments Co., Ltd.

Identifiers

510(k) Number
K173186 FDA 510(k)
FDA Product Code
GXY FDA 510(k)
Models / Variants
S55105 FDA 510(k)
S80120 FDA 510(k)
SG4040 FDA 510(k)
SG4368 FDA 510(k)
SG50D FDA 510(k)
SG5050 FDA 510(k)
SG5075 FDA 510(k)
SG50100 FDA 510(k)
SG5795 FDA 510(k)
SG60147 FDA 510(k)
SG7090 FDA 510(k)
SG75D FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.1320 FDA 510(k)
Regulation Number
882.1320 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

S Series Electrodes / (S55105 +11 more) by Everyway Medical Instruments Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 12 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Everyway Medical Instruments Co., Ltd.
FDA Applicant
Everyway Medical Instruments Co.,Ltd

Sources (1)

  • FDA 510(k) K173186 24 fields · synced Jun 18, 2026