Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033436414

FEI Number

3033436414

Entity Name

VIZOR ORTOPEDI MEDIKAL URUNLERI PAZARLAMA ITHALAT IHRACAT SANAYI VE TICARET LTD STI

City/State/Country

KUCUKCEKMECE Istanbul, TR

Establishment Address

K.3, NO:26B HALKALI MERKEZ MAHALLESI SEHIT ISMET CAVUS SOKAK DEREBOYU CADDESI,, KUCUKCEKMECE Istanbul 34303, TR

Establishment Type(s)

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

Owner / Operator

VIZOR ORTOPEDI MEDIKAL URUNLERI PAZARLAMA ITHALAT IHRACAT SA (Owner Number: 10091542)

Owner / Operator Contact Address

K.3, NO:26B HALKALI MERKEZ MAHALLESI SEHIT ISMET CAVUS SOKAK DEREBOYU CADDESI,, KUCUKCEKMECE, TR-34 34303, TR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

1005 REFLEX AFO (R/L) 315 SILICONE ARCH SUPPORT (ADHESIVE) 310-LUX SILICONE INSOLES FULL LENGTH 706 ACHILLES TENDON ANKLE SUPPORT (Sizes S - XXL) 19-UNV STANDARD WRIST SPLINT BF0006 FITTECH STAR ANKLE SUPPORT (S-XL) 327 SILICONE HAMMER TOE CUSHION 310 SILICONE INSOLE 5819 FITTECH WRIST SPLINT (R/L) (Sizes S - XL) 1003 ACHILLES BOOT (S-L) 311 SILICONE HEEL CUP 324 SILICONE METATARSAL PAD WITH LOOP (STANDARD) 907 ELASTIC HALLUX VALGUS SPLINT (STANDARD) 705 WOVEN MALLEOLAR ANKLE SUPPORT 903-UNV NEOPRENE LIGAMENT ANKLE SUPPORT (STANDARD) 604-ES AIRTEX HINGED KNEE SUPPORT 5842 FITTECH STAR ANKLE SUPPORT (S-XL) 900-ES AIRTEX FLEXIBLE ANKLE SUPPORT 1001-P ANKLE BRACE WITH PAD 902 NEOPRENE MALLEOLAR ANKLE SUPPORT (Sizes S - XXL) 1001 ANKLE BRACE WITH AIR (AIR CAST) (STANDARD) 321 STARFLEX INSOLE (NO:36 to 44) 911 CAST SHOES (S-XL) 300 SILICONE TOE RING 323-B SILICONE BUNION SHIELD AND TOE SPREADER 325 SILICONE METATARSAL PAD WITH WEDGED (STANDARD) 901-ES AIRTEX CROSS ANKLE SUPPORT 318 CORK INSOLE (NO:36 to 44) 905 DORSIFLEXION BANDAGE 603 STANDARD PATELLA AND LIGAMENT KNEE SUPPORT 308 NEOPRENE SIMPLE WRISTBAND UNV 309 NEOPRENE WRISTBAND 326 SILICONE BUNION SHIELD (STANDARD) BF0005 FITTECH WRIST SPLINT (R/L) (Sizes S - XL) 321-E STARFLEX INSOLE WITH CUSHIONING (NO:36 to 44) 601-ES AIRTEX SIMPLE KNEE SUPPORT 903-ES AIRTEX LIGAMENT ANKLE SUPPORT 313 SILICONE MEDIAL & LATERAL WEDGE(ADHESIVE) 1001-J ANKLE BRACE WITH GEL 319 CORK INSOLE WITH CUSHIONING (NO:36 to 44) 5840 FITTECH ANKLE SUPPORT (S-L) 602-ES AIRTEX PATELLA KNEE SUPPORT 1000 DYNAMIC FOOT GUARD AFO 704 WOVEN ANKLE SUPPORT 902-ES AIRTEX MALLEOLAR ANKLE SUPPORT 910 HALLUX VALGUS SHOES (S-XL) 904 LACE-UP ANKLE SUPPORT 802-ES AIRTEX CALF SUPPORT 906 HALLUX VALGUS NIGHT SPLINT (STANDARD) (R/L) 312 SILICONE INSOLE COVERED WITH FABRIC (XS-XXL) 801 NEOPRENE THIGH SUPPORT 902-UNV NEOPRENE MALLEOLAR ANKLE SUPPORT (STANDARD) 317 CALCANEUS HEEL SUPPORT (M-L) 7704 SPORT ANKLE SUPPORT (S-XXL) 21-ES AIRTEX WRIST SPLINT WITH THUMB SUPPORT 1301 AIRTECH AIR WALKER (LONG) (S-L) 1300 AIRTECH AIR WALKER (SHORT) (S-L) 901-UNV NEOPRENE CROSS STRAP ANKLE SUPPORT (STANDARD) 311-C SILICONE HEEL COMFORT (S-L) 901 CROSS STRAP ANKLE SUPPORT (Sizes S - XXL) 1004-LUX LUX FOOT GUARD 604 STANDARD HINGED KNEE SUPPORT 323 SILICONE TOE SPREADER 1002 R.O.M. WALKER (S-L) 1004 FOOT GUARD 903 LIGAMENT ANKLE SUPPORT (S-XXL) 603-ES AIRTEX PATELLA AND LIGAMENT KNEE SUPPORT 801-ES AIRTEX THIGH SUPPORT BF0008 COMPREFLEX CALF TALL (S-XXL) 316 HEEL CUP (ADHESIVE) 161-UNV POSTUREX BANDAGE STANDARD 161 POSTUREX BANDAGE VK-208-LUX CLAVICLE BANDAGE VK-204 VELPAU BANDAGE (XXXS - XXS - XS) 212 GABARDINE ARM SLING 5834 FITTECH EPICONDYLITIS BANDAGE (S - M) 1 - (L - XL - XXL) 2 5501 CCL1 (18-21mmHg) LYMPH EDEMA SLEEVE FINGER TO SHOULDER WITH A STRAP 304-J EPICONDYLITIS BANDAGE WITH GEL PAD 214 VELPAU BANDAGE ULTRA 5600 CCL2 (23-32mmHg) LYMPH EDEMA SLEEVE FINGER TO SHOULDER WITH SILICONE BAND 5500 CCL1 (18-21mmHg) LYMPH EDEMA SLEEVE FINGER TO SHOULDER WITH SILICONE BAND 206 ARM SLING (45-60 DEGREES) 207-UNV STANDART SHOULDER SUPPORT 202 ARM SLING (PERFORATED) 5601 CCL2 (23-32mmHg) LYMPH EDEMA SLEEVE FINGER TO SHOULDER WITH A STRAP 204 VELPAU BANDAGE 203 ARM SLING (Sizes S - XXL) 304-S EPICONDYLITIS BANDAGE WITH SILICONE PAD VK-203 ARM SLING (XXXS - XXS - XS) 1024 RIGHT ELBOW ROM ORTHOSIS 201 ARM SLING SIMPLE STANDARD 304 NEOPRENE EPICONDYLITIS BANDAGE 205 ARM SLING (30 DEGREES) 1145-55-65 KNEE IMMOBILIZER (45CM) 1000 DYNAMIC FOOT GUARD AFO 1005 REFLEX AFO 430 SACROILIAC CORSET (Sizes S - XXL) 7125 ADJUSTABLE WEIGHT (1-2-3-4-5 KG) 7115 EXERCISE BAND (YELLOW (SOFT)) 310 SILICONE INSOLE (Sizes XS - XXL); 912 BREAST FORM BRA 315 SILICONE ARCH SUPPORT (ADHESIVE) (S-L) 7110 PORTABLE TOILET RISER (STANDARD) 311 SILICONE HEEL CUP (S-L) 324 SILICONE METATARSAL PAD WITH LOOP (STANDARD) 744 ACTIVE SPORT INSOLE (S-XL) 7119 PAIN RELIEF TAPE (BLUE,PINK,BEIGE,BLACK,RED) 325 SILICONE METATARSAL PAD WITH WEDGED (STANDARD) 740 AIR SUSPENSION INSOLE (S-XXL) 322 STEEL INSOLE (NO 36-44) 316 HEEL CUP (ADHESIVE) (S-XL) 323-B SILICONE BUNION SHIELD AND TOE SPREADER (STANDARD) 300 SILICONE TOE RING (S-L) 323 SILICONE TOE SPREADER (S-L) 313 SILICONE MEDIAL & LATERAL WEDGE(ADHESIVE) (S-XL) 742 MEMORY FOAM INSOLE (S-XL) 741 DYNAMIC SPORT INSOLE (S-XL) 913 SILICONE BREAST FORM 310-LUX SILICONE INSOLES FULL LENGTH (Sizes XS - XXL); 743 ANATOMIC DESIGN INSOLE (S-XL) 328 SILICONE STRESS BALL 429 INGUINAL TRUSS (SINGLE SIDED) 1120 SUSPENSORY VK-429 CHILD INGUINAL HERNIA TRUSS (SINGLE SIDED) (STANDARD) (R/L) 429-C INGUINAL TRUSS (DOUBLE SIDED) VK-424 CHILD UMBILICAL HERNIA TRUSS (STANDARD) 1013 REFLUX PILLOW 1011 VISCO NECK SUPPORT PILLOW-(MEDIUM) VK-1019 KIDS POSITION PILLOW (18X25X12/12) 1019 POSITION PILLOW 1010 VISCO NECK SUPPORT PILLOW-(SMALL) 1011-B VISCO NECK SUPPORT PILLOW- (LARGE) 1012-C COMFORT VISCO TRAVEL PILLOW 1116 VISCO ANATOMIC SITTING PILLOW 1011-J VISCO NECK SUPPORT GEL PILLOW (57X37X11/7) 1012 VISCO NECK PILLOW FOR TRAVEL 1117 COCCYX SITTING PILLOW VK-1013 CHILD REFLUX PILLOW (55x50x10) 1014 WAIST SUPPORT PILLOW 1112 VISCO CLASSIC PILLOW 1122 VISCO POSTURE CUSHION 1111-J VISCO WHEELCHAIR CUSHION WITH GEL 1117 COCCYX SITTING PILLOW 1015 VISCO WAIST SUPPORT PILLOW 1018 SITTING PILLOW-OPEN FRONT (44X12) 1111 VISCO WHEELCHAIR CUSHION 1014 WAIST SUPPORT PILLOW 1015-Y NEW GENERATION VISCO LUMBAR SUPPORT PILLOW 1116 VISCO ANATOMIC SITTING PILLOW 1121 PATIENT TURNING PILLOW 5204-K CCL2 (23-32mmHg) PANTYHOSE MEDICAL COMPRESSION STOCKINGS (CLOSED TOE) (Sizes 1 -7) 5304-A CCL2 (23-32mmHg) PANTYHOSE MEDICAL COMPRESSION STOCKINGS (OPEN TOE) (Sizes 1 -7) BFCS101 CCL1 KNEE-HIGH MEDICAL COMPRESSION STOCKINGS (CLOSE) BEIGE (1-7) 5101-K CCL1 (18-21mmHg) KNEE-HIGH MEDICAL COMPRESSION STOCKINGS (CLOSED TOE) (Sizes 1 -7) BFCS303 CCL2 THIGH-HIGH MEDICAL COMPRESSION STOCKINGS (CLOSE) BLACK (1-7) BFCS301 CCL2 KNEE-HIGH MEDICAL COMPRESSION STOCKINGS (CLOSE) BLACK (1-7) 6102 ANTI-EMBOLISM THIGH STOCKINGS (DOUBLE) (Sizes S-XXL) BFCS403 CCL1 THIGH-HIGH MEDICAL COMPRESSION STOCKINGS (CLOSE) BLACK (1-7) 5303-K CCL2 (23-32mmHg) THIGH-HIGH MEDICAL COMPRESSION STOCKINGS (CLOSED TOE) (Sizes 1 -7) 5201-K CCL2 (23-32mmHg) KNEE-HIGH MEDICAL COMPRESSION STOCKINGS BLACK (CLOSED TOE) (Sizes 1 -7) 5103-K CCL1 (18-21mmHg) THIGH-HIGH MEDICAL COMPRESSION STOCKINGS (CLOSED TOE) (Sizes 1 -7) 5201-A CCL2 (23-32mmHg) KNEE-HIGH MEDICAL COMPRESSION STOCKINGS (OPEN TOE) (Sizes 1 -7) 5600 CCL2 (23-32mmHg) LYMPH EDEMA SLEEVE FINGER TO SHOULDER WITH SILICONE BAND 5205 CCL2 (23-32mmHg) PREGNANCY PANTYHOSE MEDICAL STOCKINGS (CLOSED TOE) 5104-K CCL1 (18-21mmHg) PANTYHOSE MEDICAL COMPRESSION STOCKINGS (CLOSED TOE) (Sizes 1 -7) 5101-A CCL1 (18-21mmHg) KNEE-HIGH MEDICAL COMPRESSION STOCKINGS (OPEN TOE) (Sizes 1 -7) BFCS203 CCL2 THIGH-HIGH MEDICAL COMPRESSION STOCKINGS (CLOSE) BEIGE (1-7) 5204-A CCL2 (23-32mmHg) PANTYHOSE MEDICAL COMPRESSION STOCKINGS (OPEN TOE) (Sizes 1 -7) BFCS401 CCL1 KNEE-HIGH MEDICAL COMPRESSION STOCKINGS (CLOSE) BLACK (1-7) 5304-K CCL2 (23-32mmHg) PANTYHOSE MEDICAL COMPRESSION STOCKINGS (CLOSED TOE) (Sizes 1 -7) 5303-A CCL2 (23-32mmHg) THIGH-HIGH MEDICAL COMPRESSION STOCKINGS (OPEN TOE) (Sizes 1 -7) BFCS201 CCL2 KNEE-HIGH MEDICAL COMPRESSION STOCKINGS (CLOSE) BEIGE (1-7) 5500 CCL1 (18-21mmHg) LYMPH EDEMA SLEEVE FINGER TO SHOULDER WITH SILICONE BAND 5301-K CCL2 (23-32mmHg) KNEE-HIGH MEDICAL COMPRESSION STOCKINGS (CLOSED TOE) (Sizes 1 -7) 5203-K CCL2 (23-32mmHg) THIGH-HIGH MEDICAL COMPRESSION STOCKINGS (CLOSED TOE) (Sizes 1 -7) 5103-A CCL1 (18-21mmHg) THIGH-HIGH MEDICAL COMPRESSION STOCKINGS (OPEN TOE) (Sizes 1 -7) 5601 CCL2 (23-32mmHg) LYMPH EDEMA SLEEVE FINGER TO SHOULDER WITH A STRAP 5104-A CCL1 (18-21mmHg) PANTYHOSE MEDICAL COMPRESSION STOCKINGS (OPEN TOE) (Sizes 1 -7) 5203-A CCL2 (23-32mmHg) THIGH-HIGH MEDICAL COMPRESSION STOCKINGS (OPEN TOE) (Sizes 1 -7) 5301-A CCL2 (23-32mmHg) KNEE-HIGH MEDICAL COMPRESSION STOCKINGS (OPEN TOE) (Sizes 1 -7) BFCS103 CCL1 THIGH-HIGH MEDICAL COMPRESSION STOCKINGS (CLOSE) BEIGE (1-7) 5501 CCL1 (18-21mmHg) LYMPH EDEMA SLEEVE FINGER TO SHOULDER WITH A STRAP 108 PHILADELPHIA TRACHEOSTOMY COLLAR 302 TENNIS ELBOW SUPPORT 802 NEOPRENE CALF SUPPORT (Sizes S - XXL); 304-S EPICONDYLITIS BANDAGE WITH SILICONE PAD 5850 FITTECH HALLUX VALGUS SPLINT 801-UNV STANDARD NEOPRENE THIGH SUPPORT 207-ES AIRTEX SHOULDER SUPPORT 304-J EPICONDYLITIS BANDAGE WITH GEL PAD 1006 HIP BRACE 1008 FREJKA ORTHOSIS (S-XXL) 1110 CIRCUMCISION PANTS (S-XL) 1007 PAVLIK BANDAGE 1007-LUX TUBINGEN ABDUCTION ORTHOSIS 803 RIGHT HIP SUPPORT (S-XXL) (R/L) 1040 D.K.C. ORTHOSIS (S-L) 804 SLIMMING TIGHTS (S-XXL) 1009-H DENIS BROWNE SPLINT MOBILE (SHORT AND LONG) 1009 DENIS BROWNE SPLINT IMMOBILE (SHORT AND LONG) 6102 ANTI-EMBOLISM THIGH STOCKINGS (DOUBLE) (Sizes S-XXL) 260-UNV STANDARD LUMBOSTAD CORSET 1840-1940 ABDOMINAL-KNEE-HIGH POST- OP COMPRESSION CORSET WITH STRAP 1820-1920 FEMALE POST-OP COMPRESSION SLEEVE 350 DYNAMIC DORSOLUMBER CORSET 1881-1981 HIP-FAT TRANSFER FULL BODY POST-OP COMPRESSION CORSET (KNEE-HIGH) 913 SILICONE BREAST FORM 260-K LUMBOSTAD CORSET (26cm) WITH STRAP 1801-1901 STANDARD FACE BAND 1896-1996 MALE CHEST-ABDOMINAL ARM POST-OP COMPRESSION VEST 1830-1930 POST OP COMPRESSION CORSET WITH ABDOMINAL-HIP STRAPS 260-K UNV STANDARD LUMBOSTAD CORSET 1895-1995 MALE CHEST POST-OP COMPRESSION VEST WITH ZIP 1860-1960 FULL BODY POST-OP COMPRESSION CORSET WITH SLING 330-K UNV DORSOLUMBAR CORSET STANDARD 1880-1980 HIP-FAT TRANSFER UPPER KNEE POST-OP COMPRESSION CORSET 1800-1900 FACIAL - CHIN - NECK BANDAGE 1882-1982 HIP-FAT TRANSFER FULL BODY POST-OP COMPRESSION CORSET (LOWER KNEE) 912 BREAST FORM BRA 1831-1931 ABDOMINAL-HIP POST-OP COMPRESSION CORSET 1871-1971 ABDOMINAL-LOWER KNEE POST-OP COMPRESSION CORSET 1893-1993 MALE CHEST-ABDOMINAL POST-OP COMPRESSION VEST 330-K DORSOLUMBAR CORSET 1833-1933 CHEST-ABDOMINAL- HIP POST -OP COMPRESSION CORSET 1841-1941 ABDOMINAL-LOWER KNEE POST -OP COMPRESSION CORSET WITH STRAP 1823-1923 FEMALE POST-OP COMPRESSION VEST WITH AGRAPH 423 UMBILICAL HERNIA CORSET 1890-1990 MALE CHEST-ABDOMINAL POST OP COMPRESSION CORSET 420-UNV ABDOMINAL CORSET 1891-1991 MALE CHEST-ABDOMINAL- HIP POST-OP COMPRESSION CORSET VK-330-K CHILD LUMBAR BACK BRACE (XXS-XS) 420-D ABDOMINAL CORSET (16 CM) 428 PREGNANCY CORSET 1842-1942 CHEST-ABDOMINAL POST -OP COMPRESSION CORSET 1872-1972 ABDOMINAL-UPPER&LOWER LEG POST -OP COMPRESSION CORSET 420-K COLOSTOMY CORSET 429 INGUINAL TRUSS (SINGLE SIDED) 423 UMBILICAL HERNIA CORSET (Sizes S - XXL); 420-DK16 COLOSTOMY CORSET (16CM) (S-XXL) 429-C INGUINAL TRUSS (DOUBLE SIDED) 420-DK26 COLOSTOMY CORSET (26CM) (S-XXL) 802-UNV STANDARD NEOPRENE CALF SUPPORT 602 STANDARD PATELLA KNEE SUPPORT (Kids Size Available) 601 STANDARD SIMPLE KNEE SUPPORT 510 KNEE SUPPORT FOR POST-ARTHROSCOPY (Sizes S-XXL) 702 WOVEN PATELLA KNEE SUPPORT (Sizes S - XXL); VK-902 MALLEOLAR ANKLE SUPPORT (S-L) 3 WOOLEN KNEE SUPPORT 504-AK HINGED KNEE SUPPORT (Open Front) (Sizes S-XXL) 507 NEOPRENE KNEE ANGLE-ADJUSTED (Sizes S-XXL) 708 WOVEN HINGED KNEE SUPPORT (Sizes S-XXL) 501 PATELLA KNEE SUPPORT 7701 SPORT KNEE SUPPORT BF0002 KNEE BRACE ANGLE-ADJUSTED PULL ON (S-XXL) 900 STANDARD FLEXIBLE ANKLE SUPPORT 503-A PATELLA AND LIGAMENT KNEE SUPPORT (Open Top) VK-501 PATELLA KNEE SUPPORT (S-L) 502 PATELLA AND LIGAMENT KNEE SUPPORT BF0009 COMPREFLEX CALF REGULAR (S-XXL) 508 PATELLAR STABILIZATION KNEE SUPPORT 503 PATELLA AND LIGAMENT KNEE SUPPORT WITH VELCRO 504-A HINGED KNEE SUPPORT (Open Top) (Sizes S-XXL) 1106 ANGLE-ADJUSTED BRACE (LUX) 509 KNEE SUPPORT WITH PAD (Sizes S-XXL) 511 KNEE SUPPORT FOR PATELLAR TENDON 701 WOVEN KNEE SUPPORT (Sizes S - XXL); 1105 ANGLE-ADJUSTED BRACE (COMFORT) 1103 ANGLE- ADJUSTED BRACE 1125-30-35-40 KIDS KNEE IMMOBILIZER 504 HINGED KNEE SUPPORT (Sizes S-XXL) 703 PATELLA AND LIGAMENT WOVEN KNEE SUPPORT (Sizes S - XXL); BF0001 KNEE BRACE ANGLE-ADJUSTED WRAP (S-XXL) 902 NEOPRENE MALLEOLAR ANKLE SUPPORT (Sizes S-XXL) BF60501 KNEE BRACE ANGLE-HINGED WRAP (S-XXL) 4 CAMEL WOOL KNEE SUPPORT 512 NEOPRENE PATELLAR TENDON BAND 802 NEOPRENE CALF SUPPORT BF0003 WOVEN HINGED KNEE SUPPORT (Sizes S-XXL) 1009-A DENIS BROWNE BOOT (NO:12 to 27) 506 KNEE SUPPORT FOR ANT.CRUCIATE LIGAMENT (Sizes S-XXL) 1145-1155-1165 KNEE IMMOBILIZER (45CM,55CM,65CM) (STANDARD) 500 SIMPLE KNEE SUPPORT (Sizes S - XXL); 1107 MOBILE ADJUSTABLE KNEE SUPPORT 37 PROXIMAL SPLINT 32 FINGER STABILIZER SPLINT 204-UNV STANDART VELPAU BANDAGE 8301-ES LONG WRIST BRACKET WITH THUMB SUPPORT,AIRTEX,MULTIPURPOSE FINGER SPLINT-STANDARD (S-M) 1- (L-XXL) 2 (R/L) 309 NEOPRENE WRISTBAND (STANDARD) 19-N NEOPRENE WRIST SPLINT 303 ELBOW SUPPORT WITH PAD (S-XXL) 1024 RIGHT ELBOW R.O.M ORTHOSIS 303-UNV ELBOW SUPPORT WITH PAD (UNV) 308 NEOPRENE SIMPLE WRISTBAND UNV 19-UNV STANDARD WRIST SPLINT (R/L) 38 MULTI FINGER (1-14); 207 SHOULDER SUPPORT (S-XXL) 305 EPICONDYLITIS SPLINT 31 STRAIGHT FINGER SPLINT (STANDARD) VK-19 NEOPRENE WRIST SPLINT (S-L) 314 SILICONE METATARSAL ARCH SUPPORT (ADHESIVE) (S-M) 7019 SPORT HAND WRIST SUPPORT 22-ES AIRTEX MULTIPURPOSE FINGER SPLINT 1022 THERMOPLASTIC ANTI-SPASTICITY HAND SPLINT (S-L) (R/L) 328 SILICONE STRESS BALL (3 Resistance levels: Red = Hard , Blue = Medium, Green = Soft ); 13 DE QUERVAIN SPLINT PRO 19-LUX HAND WRIST SPLINT WITH THUMB SUP.AIRTEX FAB 36 MALLET FINGER 35 BUTTONHOLE SPLINT 403 CUBITAL TUNNEL ELBOW SUPPORT (S-XXL) 15-ES AIRTEX DE QUERVAIN SPLINT 304 NEOPRENE EPICONDYLITIS BANDAGE 207-ES AIRTEX SHOULDER SUPPORT 8300-ES AIRTEX EXTRA LONG WRIST SPLINT STANDARD (S-M) 1- (L-XL-XXL) 2 1028 THERMOPLASTIC KLEINERT HAND FINGER SPLINT (M-L) (R/L) 7306 SPORT ELBOW SUPPORT (Sizes S - XXL) 19-ES AIRTEX WRIST SPLINT (R/L) 33 FROG SPLINT 21-UNV STD. WRIST SPLINT WITH THUMB SUPPORT (R/L) 5821 FITTECH WIRST SPLINT WITH THUMB SUPPORT (S-XL (R/L) 301 ELASTIC ELBOW SUPPORT (S-XXL) 21-ES AIRTEX WRIST SPLINT WITH THUMB SUPPORT (R/L) 19-C KNITTED HAND WRIST SPLINT (S-XXL) 21 WRIST SPLINT WITH THUMB SUPPORT (Sizes S - XXL); 302-UNV TENNIS ELBOW SUPPORT UNV 34 BASEBALL SPLINT 1021 THERMOPLASTIC WRIST IMMOBILIZATION SPLINT (S-L) (R/L) 1026 ELBOW ANGLE-ADJUSTED (S-XXL) 210 HUMERUS BRACE S (1) - M (2) 19-B LACE UP WRIST SPLINT 306 WOVEN ELBOW SUPPORT (S-XXL) 1027 ADJUSTABLE DYNAMIC ARM CONTRACTOR STANDARD (R/L) 21-B WRIST SPLINT WITH THUMB SUPPORT (Sizes S - L); (R/L) 19 WRIST SPLINT (LONG) (S - XXL); (R/L) 16 WRIST SPLINT (SHORT) (S - XXL); (R/L) VK-21 WRIST SPLINT WITH THUMB SUPPORT (S-L) 19-F STATIC HAND WRIST WITH AIRTEX FABRIC 15 DE QUERVAIN SPLINT (S-XXL) 307 WOVEN EPICONDYLITIS ELBOW SUPPORT (S-XXL) 15-UNV STANDARD DE QUERVAIN SPLINT 5819 FITTECH WRIST SPLINT (R/L) (Sizes S - XL) 1025 ELBOW IMMOBILIZER (S-XXL) 1020 THERMOPLASTIC HAND IMMOBILIZATION SPLINT (S-L) (R/L) 1023 THERMOPLASTIC DYNAMIC HAND FINGER SPLINT (S-L) (R/L)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2024-10-15
IQJ	Splint, Clavicle	Physical Medicine	Class 1	890.3490	2024-10-15
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2024-10-15
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2024-10-15
IPW	Orthosis, Sacroiliac, Soft	Physical Medicine	Class 1	890.3490	2024-10-15
KYS	Insoles, Medical	General Hospital	Class 1	880.6280	2024-10-15
EXM	Truss, Umbilical	Gastroenterology, Urology	Class 1	876.5970	2024-10-15
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2024-10-15
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2024-10-15
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2024-10-14
IQF	Orthosis, Cervical-Thoracic, Rigid	Physical Medicine	Class 1	890.3490	2024-10-15
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2024-10-15
IOZ	Splint, Abduction, Congenital Hip Dislocation	Physical Medicine	Class 1	890.3665	2024-10-15
DWL	Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)	General Hospital	Class 2	880.5780	2024-10-15
IPX	Orthosis, Rib Fracture, Soft	Physical Medicine	Class 1	890.3490	2024-10-15
EXN	Support, Hernia	Gastroenterology, Urology	Class 1	876.5970	2024-10-15
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2024-10-15
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2024-10-15

Official Correspondent

Recep Bayrak

US Agent Details

RECEP BAYRAK Business: ALKAN SHOES LLC Email: bayrak.rcp@gmail.com Phone: (609) 7438847

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Same Entity

VIZOR ORTOPEDI MEDIKAL URUNLERI PAZARLAMA ITHALAT IHRACAT SA

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033436414. Last updated year: 2026. Please use registration number 3033436414 when referencing this establishment in official correspondence.