510(k) clearances

Power Wheelchair (YH-E6011,YH-E6013A)

Ningbo Youhuan Automation Technology Co., Ltd. · Physical Medicine

K250134Substantially EquivalentTraditionalITI
Open FDA's page for this record
Third party flag
N
City
Ningbo
Advisory committee description
Physical Medicine
Address 1
Rm. 103-24, # 352, # 277 Shui St.
Address 2
# 756 Tiantong S. Rd., Yinzhou District
Statement or summary
Summary
Product code
ITI
Zip code
315000
Applicant
Ningbo Youhuan Automation Technology Co., Ltd.
Decision date
2025-03-26
Decision code
SESE
Country code
CN
Device name
Power Wheelchair (YH-E6011,YH-E6013A)
Advisory committee
PM
Contact
Francis Xu
K number
K250134
Date received
2025-01-17
Review advisory committee
PM
Postal code
315000
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Wheelchair, Powered
Medical specialty description
Physical Medicine
Regulation number
890.3860
Device class
2
Registration number
3034732597, 3015992762, 3020155847, 3030410174, 3048285037, 3008597995, 3007771912, 3036988603, 1531186, 9618009, 3021374638, 3016195086, 3021959198, 3035782854, 1221084, 3008812160, 3033860076, 3007963811, 3038189190, 3033848621, 3019677893, 3017278503, 3002667030, 3044470904, 3032014158, 3030226288, 3003882673, 3043105164, 3019842343, 3011523631, 3022159079, 3006541027, 1220973, 3030822491, 3008717361, 8030931, 3005619729, 3032587493, 3006160539, 2027797 +86 more
FEI number
3034732597, 3015992762, 3020155847, 1000646143, 3030410174, 3048285037, 3008597995, 3007771912, 3036988603, 3003190528, 3021374638, 3016195086, 3005068474, 3021959198, 3035782854, 1221084, 3008812160, 3033860076, 3007963811, 3038189190, 3033848621, 3019677893, 3017278503, 3002667030, 3044470904, 3032014158, 3030226288, 3003882673, 3043105164, 3019842343, 3011523631, 3022159079, 3006541027, 1220973, 1000334118, 3030822491, 3008717361, 3003327839, 3005619729, 3032587493 +86 more
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

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.