FORTUNE COMPANY LTD.

FDA Device Registration & Listing · Huizhou Guangdong, CN · Registration 3013198248

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013198248
FEI Number
3013198248
Entity Name
FORTUNE COMPANY LTD.
City/State/Country
Huizhou Guangdong, CN
Establishment Address
Xintang Section, Xihu Village, Quichang Subdistrict, Huiyang District, Huizhou Guangdong 516221, CN
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device
Owner / Operator
Fortune Company Ltd. (Owner Number: 10056738)
Owner / Operator Contact Address
Xintang Section, Xihu Village, Quichang Subdistrict, Huiyang District, Huizhou, CN-GD 516221, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

JOINT, ELBOW, EXTERNAL LIMB COMPONENT, POWERED Pack, Hot Or Cold, Reusable WALKER, MECHANICAL ACCESSORIES, WHEELCHAIR ANKLE BRACE & SUPPORT, models of A01, A02, A03, A04, A05, A06, A07, A08, A09,A10 ANKLE BRACE & SUPPORT, models of A21, A22, A23, A24, A25, A26, A27, A28, A29,A30,A31,A32, A33 ANKLE BRACE & SUPPORT, models of A11, A12, A13, A14, A15, A16, A17, A18, A19,A20 Spinal brace/lumbo, models of B01, B02, B03, B04, B05, B06, B07, B08, B09,B10,B11, B12, B13 Spinal brace/lumbo, models of B14, B15, B16, B17, B18, B19, B20, B21, B22,B23,B24, B25, B26 Spinal brace/lumbo, models of B27, B28, B29, B30, B31, B32, B33, B34, B35,B36,B37, B38, B39 ORTHOSIS, LIMB BRACE JOINT, HIP, EXTERNAL BRACE JOINT, SHOULDER, EXTERNAL LIMB COMPONENT HAND, EXTERNAL LIMB COMPONENT, POWERED COMPONENT, EXTERNAL, LIMB, ANKLE/FOOT SLING, ARM CUSHION, FLOTATION STRAP, HEAD, GAS MASK CAGE, KNEE Collar, models of N01, N02,N03, N04, N05, N06, N07, N08, N09, N10, N11, N12, N13, n14, N15, N16 SLING, ARM, OVERHEAD SUPPORTED SUPPORT, ARM Knee brace, Models of K21, K22, K23, K24, K25, K26, K27, K28, K29, K30, K31, K32, K33, K34, K35, K36, K37, K38,K39, K40 Hip brace, Models of T01, T02, T03, T04 Knee brace, Models of K01, K02, K03, K04, K05, K06, K07, KO8, K09, K10, K11, K12, K13, K14, K15, K16, K17, K18,K19, K20 Knee brace, Models of K41, K42, K43, K44, K45, K46, K47, K48, K09, K50 Wristorthosis, Models of W16, W17, W18, W19, W20, W21, W22, W23, W25, W26, W27, W28, W29, W30, W24 Finger orthosis,models of M16, M17, M18, M19, M20, M21, M22, M23, M25, M26, M27, M28, M29, M30, M24 Hand orthosis, models of H01, H02, H03, H04, H05, H06, H07, HO8, H09, H10, H11, H12, H13, H14, H15, H16, H17, H18 Wristorthosis, Models of W01, W02, W03, W04, W05, W06, W07, W08, W09, W10, W11, W12, W13, W14, W15 Finger orthosis,models of M01, M02, M03, M04, M05, M06, M07, M08, M09, M10, M11, M12, M13, M14, M15 Apparatus, traction, non-powered

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IRE Joint, Elbow, External Limb Component, Powered Physical Medicine Class 1 890.3420 2018-01-13
IME Pack, Hot Or Cold, Reusable Physical Medicine Class 1 890.5700 2021-06-25
ITJ Walker, Mechanical Physical Medicine Class 1 890.3825 2018-01-13
KNO Accessories, Wheelchair Physical Medicine Class 1 890.3910 2020-03-20
ITW Joint, Ankle, External Brace Physical Medicine Class 1 890.3475 2018-01-13
IQE Orthosis, Lumbar Physical Medicine Class 1 890.3490 2018-01-13
IQI Orthosis, Limb Brace Physical Medicine Class 1 890.3475 2018-01-13
ITS Joint, Hip, External Brace Physical Medicine Class 1 890.3475 2018-01-13
IQQ Joint, Shoulder, External Limb Component Physical Medicine Class 1 890.3420 2018-01-13
IQZ Hand, External Limb Component, Powered Physical Medicine Class 1 890.3420 2018-01-13
ISH Component, External, Limb, Ankle/Foot Physical Medicine Class 1 890.3420 2018-01-13
ILI Sling, Arm Physical Medicine Class 1 890.3640 2018-01-13
KIC Cushion, Flotation Physical Medicine Class 1 890.3175 2020-03-20
BTK Strap, Head, Gas Mask Anesthesiology Class 1 868.5560 2018-01-13
ITM Cage, Knee Physical Medicine Class 1 890.3475 2018-01-13
IQK Orthosis, Cervical Physical Medicine Class 1 890.3490 2018-01-10
ILE Sling, Arm, Overhead Supported Physical Medicine Class 1 890.3475 2018-01-13
IOY Support, Arm Physical Medicine Class 1 890.3475 2018-01-13
ITQ Joint, Knee, External Brace Physical Medicine Class 1 890.3475 2018-01-13
ILH Splint, Hand, And Components Physical Medicine Class 1 890.3475 2018-01-13
HST Apparatus, Traction, Non-Powered Orthopedic Class 1 888.5850 2018-01-13

Official Correspondent

Red Cheng

US Agent Details

HUMBELINA BEATRIZ JOSE HUMBELINA Email: info@ucheegroup.com Phone: (917) 5923229

Related Public Records

Same Entity

Fortune Company Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0006-2025 Ossur H F Grjothals 5 Reykjavik Iceland 1
Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013198248. Last updated year: 2026. Please use registration number 3013198248 when referencing this establishment in official correspondence.
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