510(k) clearances

Powered Mobility Scooter

Intradin (Shanghai) Machinery Co., Ltd. · Physical Medicine

K250027Substantially EquivalentSpecialINI
Open FDA's page for this record
Third party flag
N
City
Shanghai
Advisory committee description
Physical Medicine
Address 1
# 118, Duhui Rd., Minhang District
Statement or summary
Statement
Product code
INI
Zip code
Shanghai
Applicant
Intradin (Shanghai) Machinery Co., Ltd.
Decision date
2025-02-21
Decision code
SESE
Country code
CN
Device name
Powered Mobility Scooter
Advisory committee
PM
Contact
Mark Li
K number
K250027
Date received
2025-01-06
Review advisory committee
PM
Postal code
Shanghai
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
Vehicle, Motorized 3-Wheeled
Medical specialty description
Physical Medicine
Regulation number
890.3800
Device class
2
Registration number
9616881, 2531465, 3019842343, 3012521614, 3043105518, 3004142507, 3034732597, 3015992762, 3044425292, 3022159079, 3034989977, 3032013112, 3026585646, 3013973449, 3037000105, 3006541027, 3020640553, 3016969129, 3012538618, 3029926469, 1528161, 3022982004, 3008597995, 3007771912, 3011191255, 3009265647, 3015726735, 3030822491, 3042262539, 3017676057, 9618009, 3016733848, 3012781455, 8043717, 3007608806, 9616873, 3008717361, 3003820676, 3008841035, 3016195086 +36 more
FEI number
3019842343, 3012521614, 3043105518, 3004142507, 3034732597, 3015992762, 3044425292, 3022159079, 3034989977, 3032013112, 1000646143, 3026585646, 3013973449, 3037000105, 3006541027, 3020640553, 3016969129, 1000334118, 3012538618, 3029926469, 3022982004, 3008597995, 3007771912, 3011191255, 3009265647, 3003190528, 3002608037, 3015726735, 3042262539, 3017676057, 3016733848, 3012781455, 3030822491, 3007608806, 3008717361, 3003820676, 3008841035, 3016195086, 3013934051, 3035382637 +36 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.