510(k) clearances

Electrically powered wheelchair

Kunshan Hi-Fortune Health Products Co., Ltd. · Physical Medicine

K244003Substantially EquivalentTraditionalITI
Open FDA's page for this record
Third party flag
N
City
Kunshan
Advisory committee description
Physical Medicine
Address 1
#625 Juxiang Rd., Zhangpu Town
Statement or summary
Summary
Product code
ITI
Zip code
215321
Applicant
Kunshan Hi-Fortune Health Products Co., Ltd.
Decision date
2025-03-26
Decision code
SESE
Country code
CN
Device name
Electrically powered wheelchair
Advisory committee
PM
Contact
Zhanli Tian
K number
K244003
Date received
2024-12-26
Review advisory committee
PM
Postal code
215321
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
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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.