510(k) K222770

Conductive Gel by Top-Rank Health Care Co., Ltd. — Product Code GYB

K222770 is an FDA 510(k) premarket notification submitted by Top-Rank Health Care Co., Ltd. for the device "Conductive Gel". The FDA issued a decision of Substantially Equivalent on December 13, 2022. The device falls under product code GYB (Media, Electroconductive), a Class II device regulated under 21 CFR 882.1275. Top-Rank Health Care Co., Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2022
Date Received
September 14, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Electroconductive
Device Class
Class II
Regulation Number
882.1275
Review Panel
NE
Submission Type