510(k) K222770
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