BEUDAMED
    FDA Registration Active 🇻🇳 Vietnam

    Foundation Wellness International Co., LTD (FWIL)

    Reg #: 3007076137 · FEI: 3007076137 · Expires 2026
    View on FDA
    Products
    31
    Proprietary Names
    597
    Establishment Types
    2
    Classifications
    31

    Registration Details

    Registration Name
    Foundation Wellness International Co., LTD (FWIL)
    Registration Number
    3007076137
    FEI Number
    3007076137
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Lot C-8C-CN My Phouc Industrial Park 3, Ben Cat District
    City
    Binh Duong
    Country
    VN

    Owner / Operator

    Firm Name
    REMINGTON PRODUCTS COMPANY LLC
    Operator Number
    1832148
    Address
    961 Seville Rd
    City
    Wadsworth
    State
    OH
    Postal Code
    44281
    Country
    US
    Correspondent
    Kenneth L Block

    US Agent

    Business Name
    Ken Block Consulting
    Contact Name
    Kenneth Block
    Address
    3400 N Central Expy Ste 100265
    City
    Richardson
    State
    TX
    ZIP
    75080
    Country
    US
    Email
    [email protected]
    Phone
    972 4809554

    Products

    Device Name Product Code
    Binder, Elastic KMO
    Orthosis, Limb Brace IQI
    Cover, Limb IPM
    Insoles, Medical KYS
    Joint, Ankle, External Brace ITW
    Tips And Pads, Cane, Crutch And Walker INP
    Orthosis, Lumbo-Sacral IPY
    Bandage, Cast ITG
    Sling, Arm ILI
    Protector, Skin Pressure FMP
    Orthosis, Sacroiliac, Soft IPW
    Binder, Abdominal FSD
    Pack, Hot Or Cold, Reusable IME
    Belt, Pelvic, Traction HSQ
    Splint, Traction HSP
    Splint, Clavicle IQJ
    Binder, Breast HEF
    Splint, Hand, And Components ILH
    Orthosis, Corrective Shoe KNP
    Support, Arm IOY
    Components, Exercise IOD
    Orthosis, Cervical IQK
    Apparatus, Traction, Non-Powered HST
    Support, Hernia EXN
    Orthosis, Lumbar IQE
    Shoe, Cast IPG
    Orthosis, Rib Fracture, Soft IPX
    Halter, Head, Traction HSS
    Splint, Abduction, Congenital Hip Dislocation IOZ
    Splint, Extremity, Non-Inflatable, External, Non-Sterile NOC
    Joint, Knee, External Brace ITQ

    Proprietary Names

    V-3001-VNS-XXL V-7100-10UN V-10960 Black 30(S-L) 000734000(28-45) V-ORT22100(XS-2XL) 000734000(50-55) V-7050-00 002735(022-025)00 V-3000-VN(M-XL)-MEBACK V-5010-03 (XS-L) AA082.300CL Wrist Brace, LG/XL - L 0135233 V-AA241.300U VN21530107-31307 V-5306-01 (A-M) (Pair) 96329-(030-160) V-MW-144-10033-35 0135221 TP-8888 AA040.300U Adjustable Elbow Support V-NS2000 (20-21) V-7200-10(UN-XL) V-5315-01 (A-M) AA280.300U Adjustable Calf Support, UN JB-TS-03-04 PPAN-66 AA320.300U Adjustable Ankle Support, UN V-AA080.300U V-7002-00 (S-L) V-BB54310UW IsoArch (A-E) V-4100 R244(11-20) V-5011-03 (XS-L) HighArch (A-E) 0135242 0135100-115 AA082.300CL Wrist Brace, LG/XL - R VN2901S/M 0135236 00065800100 V-112781-83-85 V-79-956(10-30) 0135209 AA241.300U Patella Knee Strap, UN VN21532228-3528 0135136-151 V-SR08-(A-M) (Pair) V-35055RMENXX01 V-SR08 (AA-PP) (pair) V-DynaSplint V-22073-22075 V-611-811(03-07) V-A7002 (S-L) V-SR08 (N-Z) (pair) MW-144-100(13-18) V-BB421.400U 0135239 V-VN7135(S-XL) Currex RunPro V-BB372.400(UR-UL) JB-TS-01 V-112181-95 V-AA320.300U V-215930 (0-1-2) VN215322-335 V-BY609-00 V-AA040.300U 0135206 ORT19010W(L/R)D Currex SupportPro 0135203 V-137161-73 V-7590-(02-03) (WS-WL/MS-MX) V-82000-82700 (Pair) AA080.300U Adjustable Wrist Wrap 0135212 V-AA280.300U V-BRC210(09-11) TP-9999 JB-TS-02 11208100 0135218 AA082.300AR Wrist Brace, SM/MD - R AA081.300UR Gel Wrist Support, UN - R V-111711-12-13-15 SE420.40U Plantar Fasciitis Arch Wrap, UN 0135118-133 V-7150-10(SM-XL) V-0135215 V-7005-10UN 823 (Pair) AA081.300UL Gel Wrist Support, UN - L 0135230 V-5331-01 (A-M) (Pair) VN137071-76 4200-VN(S-L) 0135227 V-AA082.300(AL-AR, CL-CR) VN-1701 S-XL 628 (Pair) V-A-5315-01 (A-M) V-VN141061-62 AA082.300AL Wrist Brace, SM/MD - L V-5315-01 (A-M) (Pair) V-AA081.300UL-UR 0135200 0135224 V-7008-10(UN-XL) V-MW-144-10036-38 Currex CleatPro V-MDSPCPMPAD V-KNE081525625 V-384899-901 EQ 20021-22022FGFCCO03 A22021-22022 2021-2022FGENWM03 22021-22022FGSPXX02 2021-2022RMENXX05 ORT28351 S-L ECB-001(S-L) V-7205-00 (S-L) V-ORT26700WD 001767(003-006)00 V-ORT27100 V-ORT26300 V-7208-10UN V-ORT28200 V-AB3000 (10-20) V-ORT27200KD 00861300454 VN1764-00 VN053912-25 V-ORT27200 V-AB3100 (10-20) V-ORT27100D ORT28400S-L ORT286100S-L V-22072 V-1763-00 V-ORT27200D V-7208-00UN V-ORT28100 V-OH-01(S-L) V-1765 V-ORT27900S-L ORT28350S-XL V-AB2900 (10-20) BRC22004-05 V-22066-220770 003453(003-006)00 V-AB-01(S-L) V-190820 V-ORT23240 V-ORT23220 001086(032-034)00 00021100100 00021700500 001086(022-024)00 001086(002-004)00 001086(012-014)00 000783(001-004)00 V-1515-(08-16) V-1520-01 660576(001-004)00 001796(011-014)00 001893(001-004)00 R1513-(08-16) (524401-312201-205) V-VN1707-00 00861400170 V-1509-00 00123200700 V-1517-(08-16) V-121980 V-ORT11400 V-120900 V-BY1509-00 00123201600 00123203800 000764(010-011)00 V-VN1011 (XS-XL) 00197800100 000784(001-005)00 V-1516-(06-12) V-MW-36-100(41-42) V-VN1705-00 000764(001-004)10 V-1514 00005600100 008600(194-195)00 V-1510-Xlong S00011203700 003898(005-008)00 V-1506 00003201500 00389900100 V-1510-00 00860179600 001892(001-004)00 000763(011, 001-004)00 00860137700 V-1513-(08-16) 00860137750 V-20-ADVCL 6084-(01-04) 001295(002-005)00 V-20-ADVCN 00267800000 001295(008-011)00 MW-144-10039-40 002721(006-008)00 V-MDS1690(22-25) 002732(010-012)00 000584(041-044)00 V-MDS1690(26-30) 002722(006-008)00 000584(031-032)00 BY-1532-00 V-SEMI30131 V-12840000 1761-00 (502001-392300) 1532-01 4051-21-41 (502001-901702-704) 1762-00 (502001-392700) V-ORT30131 609-01 (502001-901500) 62002 (502020-392700) R1532-00 (521001-502700) 1756-01B, 02B 1532-00 (501001-502700) 00077500200 00058401200 000743(003-005)00 V-1210-01 000584(021-023)00 00058401100 00167800100 00077500100 000738(002-003, 006)00 002753(011-014)00 008712(012-015)00 00177400100 002753(008-010)00 00860028200 000735(001-005)00 V-ORT14110 000735(011-015)00 V-GT500-2000 003447(303-306)(403-406)00 V-1754BL-(08-17) V-ORT19100 V-CS2239XS-2XL 1749-00 V-182520 V-ORT18110 V-ORT19400KD V-111721-22-23-25 V-VN1702-00 ORT19310L-R VN1700-UNIR-L V-ORT19400D V-102201-06 V-1742 00179800100 V-112721-22-23-25 V-VN1704-00 V-ORT18210 MW-144-100(29-30) V-1758 001759(001-008)00 V-102401-06 V-1750 000799(001-008)00 V-10220128-628 V-1749-00 V-1755BL-(01-02) V-ORT19100D V-1755BL-(08-17) V-ORT19210S-XL ORT19300L-R 001769(002-003)00 V-1753-(01-02) V-VN1703-00 V-ORT16100(XS-2XL) R1754BL-(08-17) V-P081448(33A-44A) V-ORT19810S-L V-CS2240XS-2XL V-1757 00178500100 V-1754BL-(01-02) 001799(001-010) V-1754BL-(06-07) V-ORT1900LD/RD P08144240-41 V-113721-23-25 V-SEMI1702-00 100480-83 (501012-826117-118) (501012-826217-218) V-113711-13-15 V-VN111731-46 V-112711-12-13-15 V-SEMI19810S-L V-112731-46 008601887(02-03) V-ORT19400 008600(529-530)00 V-ORT18210D V-ORT19900 V-113731-46 V-ORT30100 V-PMORT30400 V-5190-01 (S-L) V-ORT30300 V-ORT30400 V-ORT30200 V-7100(80-82) V-PMORT30300 V-ORT17100D V-ORT17110D 008614002(20-22) VN1209032-232 V-ORT17110 VN121981-83 V-ORT17100 V-ORT11700 V-CS23-6801-(S-XL) V-VN1708 (S-XL) VN120900-02 V-ORT16300 V-7025-50UN R7025-50UN V-10741 V-62820RMENCV01 00870504500 46-501003 000737(001-007)00 1001-(11-19) 00860138000 002739(001-005)00 V-ORT31400 001737(001-005)00 00176100100 002740(001-005)00 000056(008-011)00 00123203500 001232(125-128)00 V-124.P1 V-AOSG015-88(S-XL) V-03B01-(XL-7XL) V-03B01-(S-L) MW-144-10019 00173000100 V-1350-00 V-03B04-(M-4XL) V-1305-01 V-03B02-(S-3XL) 001735(021-028)00 V-1350-Xlong V-03B05(S/M-4XL) V-AA120.300A-C B05(S/M-4XL) V-AA160.300(A-C) 003449(001-002)00 VN1900XS-XL 001995(011-015)00 V-402-(11-25) 515561-490203-R1-SP V-110BL-(1-7) V141101G V-43-890, 891 V-2041-00 515561-490202-R1 V-BRC210(01-08) V-6-600A, 6-601A V-0881-83 V-7500-01 V-2033 V-443-(11-25) V-SEMI10340-343 V-2004 V-A152505-607 515561-490205-R1-SP V-2032 V-198, 199 V-442-(11-25) V-180002-18 V-2007 (01-10) V-18002-18 V-79-9524(2,8) V-ORT29300T-XS V-0980 V-1980, 1990 V-PMORT29100 V-4770-4950 V-0823-0827 V-POSTOP-000(21-28) V-0911-0917 V-ORT29100 V-2041 (01-09) V-447-(11-25) V-B308(XS-XL) V-1211B-(12-24) V-43-82(0400/1700) V-0990 V-308(XS-XL) V-099 V-301BL 001995(021-025)00 V-4040 515561-490204-R1 00860169701 V-4042 515561-490204-R1-SP V-12365-68 008716(011-015) V-A152305-407 V-43-101(204-709) 515561-490205-R1 001611(021-026)00 V-100-(0-7) V-3323-3325 V-2035 V-455-(11-25) V14555-14562 V-440-(11-25) V-18002-18-R2 V-180(02-18)-R2 V-79-955(10-30) V-ORT29300XX-XXXS V-114 001991(001-006)/00860169702 V-399V 001995(009-010)00 V-400-(11-25) V-098 V-ORT30320 MW-144-10028 V-106BL-(1-7) V-B308 A79-955(10-30) V-103MB V-A15000 (2-8) V-0901-0908 V-ORT290010(XS-XL) V-18103-18 V-309(XS-XL) V-83041-44D V-MW-144-100(20-27) V-308 V-310(XS-XL) V-103BL-(1-7) V-83061-63 V-2044 V-0802-0808 515561-490203-R1 HS1003-(08-16) V-17003-18 V-2004-00 V-10340-343 V-79-9503(2,8) V-CB5.5"-11.25" V-105 V-2042 (01-03, 06-09) 515561-490202-R1-SP V-CE442-(11-25) V-A22073-A22075 V-A79-9503(2,8) V-BY4000-6&7 V-1212-01 00091200000 001778(001-003)00 V-ORT31300 00270000700 00270000300 001716(010-012)00 511061-619200 V-1819 V-7000-VN-(SM-LXL) 00860175222 V-ORT2411020-024 VN114021-23 V-1843-00 001876(503-506)24 00188050016 00188260016 V-2830-24-VN(S-XL) V-CS75-24-26 00188050026 00188350012 00188850016 V-VN2840-00 000774(001-004)00 00188250026 V-2812 001876(604-605)16 00188350022 V-7052 00188250024 V-MW-36-100(39-40) V-26867-26868 001877(503-506)16 00188350026 V-AA240.300U V-ORT2441016S-XL 00188250019 00188850026 SEMI7000-VN (SM-LXL) 001876(603-606)12 00188050024 00188260024 00188850012 V-OP-1823-00 00188250012 00188850022 V-ORT23220D V-ORT2421024 001876(503-506)16 00188260012 V-2820-24 V-CS75-22 VN114011-13 V-1842-00 V-ORT2421019 003456(003-007)00 V-10949 00188250022 003455(003-007)00 V-10(0-5)BB 001876(603-606)24 V-1821 V7000-VN-(SM-LXL)GC V-VN1706-00 001876(603-607)19 V-1823 V-7001 00188550016 001876(603-607)22 00188350019 V-1841 V-7002 00345700000 V-1813 001876(503-506)12 00188250028 V-2816, 2818 V-2830-20-VN(S-XL) V-1844-00 001877(503-506)24 00188350028 V-CS75-12-14 ORT2441020(S-XL) V-2021 (01-04) V-ORT2421016 V-1815 V-1817 00188250016 00188850024 V-ORT23230 V-ORT2431020 00188550026 003461(003-006)00 V-ORT2411101 00188050012 00188550022 003459(024-027)00 ORT23330WD 00188050028 00188350016 00188850019 V-7003-00 (R/L) V-ORT2441020L 001877(503-507)19 00188550012 V-CS75-16-18 ORT2441022(S-XL) 001877(503-507)22 00188550019 003458(103-109)00 V-CS75-20 ORT2441024(S-XL) 001876(503-507)22 00188050022 00188260022 00188550028 V-7000 V-OP-1821-00 001877(503-506)12 00188350024 V-7135 001876(503-507)19 00188050019 00188260019 V-40-311 V-OP-1819-00 00188550024 003460(023-027)00 V-ORT2411012

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)