510(k) K262664
K262664 is an FDA 510(k) premarket notification submitted by Bozhou Rongjian Medical Appliance Co., Ltd. for the device "Rongjian Self-adhesive Electrode". The FDA issued a decision of Substantially Equivalent on Oct 20, 2026. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Bozhou Rongjian Medical Appliance Co., Ltd. has 4 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 20, 2026
- Date Received
- Jul 30, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Electrode, Cutaneous
- Device Class
- Class II
- Regulation Number
- 882.1320
- Review Panel
- NE
- Submission Type
- 510(k)