K5 wheelchair (16 with swing-away footrest 18 with swing-away footrest 20 with swing-away footrest 16 with elevated foot rest(ELR) 18 with elevated foot rest(ELR) 20 with elevated foot rest(ELR))
Zhenjiang Assure Medical Equipment Co., Ltd. · Physical Medicine
Open FDA's page for this record- Third party flag
- N
- City
- Zhenjiang
- Advisory committee description
- Physical Medicine
- Address 1
- #799, Chuqiao Rd., Zhenjiang City, Jiangsu Province,China
- Statement or summary
- Summary
- Product code
- IOR
- Applicant
- Zhenjiang Assure Medical Equipment Co., Ltd.
- Decision date
- 2026-03-31
- Decision code
- SESE
- Country code
- CN
- Advisory committee
- PM
- Contact
- Ying Mei
- K number
- K260319
- Date received
- 2026-01-30
- Review advisory committee
- PM
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Device name
K5 wheelchair (16 with swing-away footrest 18 with swing-away footrest 20 with swing-away footrest 16 with elevated foot rest(ELR) 18 with elevated foot rest(ELR) 20 with elevated foot rest(ELR))
- Harmonized identifiers (openFDA)
- Device name
- Wheelchair, Mechanical
- Medical specialty description
- Physical Medicine
- Regulation number
- 890.3850
- Device class
- 1
- Registration number
- 3015772781, 1531186, 3023141620, 3010394125, 2435946, 3023189540, 3005555653, 3011707750, 3043460907, 3004473024, 3019505063, 3016601021, 3009235818, 2022883, 3015967131, 2131358, 3004496806, 3043749706, 3007608806, 3016678950, 3011422356, 3008058406, 2183191, 3008723825, 9616881, 3007160937, 3010273872, 2428983, 3012316249, 3003823002, 3011475060, 3011059051, 2085336, 3021027216, 3004013215, 1000252066, 3007019343, 3004149089, 3016734231, 3014273557 +91 more
- FEI number
- 3015772781, 1000116427, 3023141620, 3010394125, 3002653226, 3023189540, 3005555653, 2427360, 3011707750, 3043460907, 3004473024, 3019505063, 3016601021, 3009235818, 2022883, 3015967131, 3004496806, 3043749706, 1000158532, 3007608806, 3016678950, 3011422356, 3008058406, 2183191, 3008723825, 3007160937, 3010273872, 3012316249, 3003823002, 3011475060, 3011059051, 3007074101, 3021027216, 3004013215, 3000210114, 1000253203, 1000252066, 3007019343, 3004149089, 3016734231 +91 more