510(k) clearances

Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009)

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

K241374Substantially EquivalentTraditionalIOR
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 Mingguang
Statement or summary
Summary
Product code
IOR
Zip code
239400
Applicant
Anhui Jbh Medical Apparatus Co., Ltd.
Decision date
2025-02-28
Decision code
SESE
Country code
CN
Device name
Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009)
Advisory committee
PM
Contact
Yuanwei Wei
K number
K241374
Date received
2024-05-15
Review advisory committee
PM
Postal code
239400
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Wheelchair, Mechanical
Medical specialty description
Physical Medicine
Regulation number
890.3850
Device class
1
Registration number
3032597250, 3019505063, 3042372518, 3011889389, 3012986146, 2437956, 3015058854, 3030410174, 3014421917, 3005150489, 2081283, 1531186, 9618009, 3017171467, 3004577612, 1931307, 1221084, 3019677893, 3011475060, 3005858417, 3004727093, 3015967131, 3044470904, 2428983, 3011422356, 3007120364, 3010394125, 3013538349, 1417592, 3006799874, 9681827, 3016601021, 3011059051, 3009235796, 2029329, 3005720080, 3010273872, 3030452839, 3014293077, 3012316249 +91 more
FEI number
3032597250, 3019505063, 3042372518, 3011889389, 3012986146, 3015058854, 3030410174, 3014421917, 3005150489, 3000210114, 2081283, 3004577612, 3017171467, 3005068474, 1931307, 1221084, 3019677893, 3011475060, 3005858417, 3004727093, 3015967131, 3002357954, 3044470904, 3011422356, 1000137528, 3007120364, 3010394125, 3013538349, 1417592, 3006799874, 3016601021, 3011059051, 3009235796, 3005720080, 3010273872, 3030452839, 3014293077, 3012316249, 3009235818, 3003327839 +91 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.