Fortune Co L T D

FDA Filings

This page includes the latest FDA filings for Fortune Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3013198248
FEI Number3013198248
NameFORTUNE COMPANY LTD.
Owner & OperatorFortune Company Ltd.
Contact AddressXintang Section, Xihu Village, Quichang
Huizhou CN-44 Guangdong 516221 CN
Official Correspondent
  • Red Cheng
  • 86-752-3772220-x
US Agent
Importing Logistics Registration
ImporterBreg,Inc.
Address2885 Loker Ave. East Carlsbad
Carlsbad, CA 92010 UNITED STATES
Phone1 760 7955861
Importer TypeAgent
Importing Logistics Registration
ImporterDicarre LLC
AddressTrevose, PA 19053
Trevose, PA 19053 UNITED STATES
Email Addresshumberto@dicarre.com
Phone1 267 9807415
Importer TypeAGENT
Importing Logistics Registration
ImporterThuasne USA
Address4401 STINE road
Bakersfield, CA 93313 UNITED STATES
Email Addressahowells@thuasneusa.com
Importer TypeAGENT
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressXintang Section, Xihu Village, Quichang Subdistrict, Huiyang Dis
Huizhou Guangdong, 516221 CN
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
FORTUNE COMPANY LTD.
ACCESSORIES, WHEELCHAIR2020-03-20
FORTUNE COMPANY LTD.
CUSHION, FLOTATION2020-03-20
FORTUNE COMPANY LTD.
Orthosis, foot drop2018-01-13
FORTUNE COMPANY LTD.
ANKLE BRACE & SUPPORT, models of A21, A22, A23, A24, A25, A26, A27, A28, A29,A30,A31,A32, A332018-01-13
FORTUNE COMPANY LTD.
ANKLE BRACE & SUPPORT, models of A11, A12, A13, A14, A15, A16, A17, A18, A19,A202018-01-13
FORTUNE COMPANY LTD.
ANKLE BRACE & SUPPORT, models of A01, A02, A03, A04, A05, A06, A07, A08, A09,A102018-01-13
FORTUNE COMPANY LTD.
JOINT, HIP, EXTERNAL BRACE2018-01-13
FORTUNE COMPANY LTD.
Knee brace, Models of K41, K42, K43, K44, K45, K46, K47, K48, K09, K502018-01-13
FORTUNE COMPANY LTD.
Knee brace, Models of K21, K22, K23, K24, K25, K26, K27, K28, K29, K30, K31, K32, K33, K34, K35, K36, K37, K38,K39, K402018-01-13
FORTUNE COMPANY LTD.
Knee brace, Models of K01, K02, K03, K04, K05, K06, K07, KO8, K09, K10, K11, K12, K13, K14, K15, K16, K17, K18,K19, K202018-01-13
FORTUNE COMPANY LTD.
Hip brace, Models of T01, T02, T03, T042018-01-13
FORTUNE COMPANY LTD.
CAGE, KNEE2018-01-13
FORTUNE COMPANY LTD.
WALKER, MECHANICAL2018-01-13
FORTUNE COMPANY LTD.
COMPONENT, EXTERNAL, LIMB, ANKLE/FOOT2018-01-13
FORTUNE COMPANY LTD.
JOINT, ELBOW, EXTERNAL LIMB COMPONENT, POWERED2018-01-13
FORTUNE COMPANY LTD.
HAND, EXTERNAL LIMB COMPONENT, POWERED2018-01-13
FORTUNE COMPANY LTD.
JOINT, SHOULDER, EXTERNAL LIMB COMPONENT2018-01-13
FORTUNE COMPANY LTD.
SPLINT, CLAVICLE2018-01-13
FORTUNE COMPANY LTD.
ORTHOSIS, LIMB BRACE2018-01-13
FORTUNE COMPANY LTD.
Spinal brace/lumbo, models of B27, B28, B29, B30, B31, B32, B33, B34, B35,B36,B37, B38, B392018-01-13
FORTUNE COMPANY LTD.
Spinal brace/lumbo, models of B14, B15, B16, B17, B18, B19, B20, B21, B22,B23,B24, B25, B262018-01-13
FORTUNE COMPANY LTD.
Spinal brace/lumbo, models of B01, B02, B03, B04, B05, B06, B07, B08, B09,B10,B11, B12, B132018-01-13
FORTUNE COMPANY LTD.
SUPPORT, ARM2018-01-13
FORTUNE COMPANY LTD.
SLING, ARM2018-01-13
FORTUNE COMPANY LTD.
Wristorthosis, Models of W16, W17, W18, W19, W20, W21, W22, W23, W25, W26, W27, W28, W29, W30, W242018-01-13
FORTUNE COMPANY LTD.
Wristorthosis, Models of W01, W02, W03, W04, W05, W06, W07, W08, W09, W10, W11, W12, W13, W14, W152018-01-13
FORTUNE COMPANY LTD.
Hand orthosis, models of H01, H02, H03, H04, H05, H06, H07, HO8, H09, H10, H11, H12, H13, H14, H15, H16, H17, H182018-01-13
FORTUNE COMPANY LTD.
Finger orthosis,models of M16, M17, M18, M19, M20, M21, M22, M23, M25, M26, M27, M28, M29, M30, M242018-01-13
FORTUNE COMPANY LTD.
Finger orthosis,models of M01, M02, M03, M04, M05, M06, M07, M08, M09, M10, M11, M12, M13, M14, M152018-01-13
FORTUNE COMPANY LTD.
SLING, ARM, OVERHEAD SUPPORTED2018-01-13
FORTUNE COMPANY LTD.
Apparatus, traction, non-powered2018-01-13
FORTUNE COMPANY LTD.
STRAP, HEAD, GAS MASK2018-01-13
FORTUNE COMPANY LTD.
Collar, models of N01, N02,N03, N04, N05, N06, N07, N08, N09, N10, N11, N12, N13, n14, N15, N162018-01-10

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