510(k) clearances

Rongjian Self-adhesive Electrode

Bozhou Rongjian Medical Appliance Co., Ltd. · Neurology

K262664Substantially EquivalentTraditionalGXY
Open FDA's page for this record
Third party flag
N
City
Bozhou
Advisory committee description
Neurology
Address 1
Jianghuai Supply Base,Zhongkai Group,Mengcheng County
Statement or summary
Summary
Product code
GXY
Zip code
233500
Applicant
Bozhou Rongjian Medical Appliance Co., Ltd.
Decision date
2026-10-20
Decision code
SESE
Country code
CN
Device name
Rongjian Self-adhesive Electrode
Advisory committee
NE
Contact
Wu zhi fang
K number
K262664
Date received
2026-07-30
Review advisory committee
NE
Postal code
233500
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Electrode, Cutaneous
Medical specialty description
Neurology
Regulation number
882.1320
Device class
2
Registration number
3014649088, 3005581220, 3018094310, 3007028037, 3021826057, 3013298431, 3010097863, 1223925, 3004786509, 3023613474, 3045321552, 3005170249, 3008716327, 3022954003, 3012840029, 3009499478, 8030245, 3009555600, 3002923871, 3020018, 3016852448, 3019865183, 3006850006, 3010078417, 3014647250, 3015429360, 3010605876, 3006258094, 3004695199, 3010515191, 3007048259, 3005581270, 9611558, 3012134907, 9710051, 3016674095, 3043226252, 3014027738, 3009156722, 3046649655 +213 more
FEI number
3014649088, 3005581220, 3018094310, 3007028037, 3021826057, 3926, 3013298431, 3010097863, 3006076154, 3004786509, 3023613474, 3045321552, 3005170249, 3008716327, 3022954003, 1000119368, 3012840029, 3009499478, 3009555600, 1000119345, 1000208624, 3002716534, 3002923871, 3001450493, 3020018, 3016852448, 3019865183, 3006850006, 3003831320, 3010078417, 3014647250, 3015429360, 3010605876, 3006258094, 3004695199, 3010515191, 3007048259, 3005581270, 3012134907, 3016674095 +213 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.