510(k) clearance
Rongjian Self-adhesive Electrode
- 510(k) number
- K262664
- Applicant
- Bozhou Rongjian Medical Appliance Co., Ltd.
- Decision date
- Oct 20, 2026
- Date received
- Jul 30, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- GXY
- Device type
- Electrode, Cutaneous
- Device class
- Class II
- Regulation
- 21 CFR 882.1320
- Advisory committee
- Neurology
- Statement or summary
- Summary
- Third party
- N
- Location
- Bozhou, CN