510(k) clearances

Electric Scooter (FDB08, FDB08A, FDB12)

Anhui JBH Medical Apparatus Co., Ltd. · Physical Medicine

K261859Substantially EquivalentTraditionalINI
Open FDA's page for this record
Third party flag
N
City
Chuzhou
Advisory committee description
Physical Medicine
Address 1
# 116 Qicang Rd., Industrial District, Ming Guang City
Statement or summary
Summary
Product code
INI
Zip code
239000
Applicant
Anhui JBH Medical Apparatus Co., Ltd.
Decision date
2026-09-19
Decision code
SESE
Country code
CN
Device name
Electric Scooter (FDB08, FDB08A, FDB12)
Advisory committee
PM
Contact
Yuanwei Wei
K number
K261859
Date received
2026-06-04
Review advisory committee
PM
Postal code
239000
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Vehicle, Motorized 3-Wheeled
Medical specialty description
Physical Medicine
Regulation number
890.3800
Device class
2
Registration number
3008717361, 1821729, 3043153502, 3014983822, 3003882673, 3016733848, 3008812160, 8043717, 3007608806, 9680333, 3004142507, 3016195086, 3012425482, 3015992762, 3035382637, 3017816603, 3006247243, 3012781455, 3016068274, 3029926469, 3007771912, 3033860076, 3014489639, 3019984611, 3037000105, 3034732597, 2531618, 3012604975, 9616873, 3033905189, 3030226288, 3012538618, 3007675960, 3026585646, 2531465, 3004594214, 3030822491, 3008841035, 3003820676, 3022159079 +34 more
FEI number
3008717361, 1000334118, 3003327839, 1821729, 3014983822, 3003882673, 3043153502, 3016733848, 3008812160, 3002847480, 3003190528, 3007608806, 3004142507, 3016195086, 3015992762, 3012425482, 3035382637, 3017816603, 3006247243, 3012781455, 3016068274, 3029926469, 3007771912, 3033860076, 3014489639, 3019984611, 3037000105, 3034732597, 3003792251, 3012604975, 3033905189, 1000221992, 3012538618, 3007675960, 3026585646, 3030226288, 3004594214, 3030822491, 1000122747, 3008841035 +34 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.