Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007076137

FEI Number

3007076137

Entity Name

Foundation Wellness International Co., LTD (FWIL)

City/State/Country

Binh Duong, VN

Establishment Address

Lot C-8C-CN My Phouc Industrial Park 3, Ben Cat District, Binh Duong 72999, VN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

REMINGTON PRODUCTS COMPANY LLC (Owner Number: 1832148)

Owner / Operator Contact Address

961 Seville Rd, Wadsworth, OH 44281, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KMO	Binder, Elastic	General Hospital	Class 1	880.5160	2010-04-28
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	1992-11-23
IPM	Cover, Limb	Physical Medicine	Class 1	890.3025	2015-06-02
KYS	Insoles, Medical	General Hospital	Class 1	880.6280	2010-04-21
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2010-04-28
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	2017-05-09
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2010-04-28
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2011-12-05
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	1992-11-23
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2011-11-17
IPW	Orthosis, Sacroiliac, Soft	Physical Medicine	Class 1	890.3490	2011-11-17
FSD	Binder, Abdominal	General Hospital	Class 1	880.5160	2010-04-28
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2010-05-03
HSQ	Belt, Pelvic, Traction	Orthopedic	Class 1	888.5890	2011-11-17
HSP	Splint, Traction	Orthopedic	Class 1	888.5890	2011-11-17
IQJ	Splint, Clavicle	Physical Medicine	Class 1	890.3490	2011-11-17
HEF	Binder, Breast	General Hospital	Class 1	880.5160	2019-04-05
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2010-04-28
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2010-04-28
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2011-11-17
IOD	Components, Exercise	Physical Medicine	Class 1	890.5350	2015-02-17
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2010-04-28
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2011-11-17

Official Correspondent

Kenneth Block

US Agent Details

Kenneth Block Business: Ken Block Consulting Email: k.block@kenblockconsulting.com Phone: (972) 4809554

Related Public Records

Same Entity

REMINGTON PRODUCTS COMPANY LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3009134760	Stable Step LLC	West Chester, OH, US
1523560	REMINGTON PRODUCTS COMPANY LLC	WADSWORTH, OH, US

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 3007076137. Last updated year: 2026. Please use registration number 3007076137 when referencing this establishment in official correspondence.