FDA Registration
Active
🇹🇷 Türkiye
1004 FOOT GUARD
Reg #: 3033436414
·
FEI: 3033436414
·
Expires 2025
Products
1
Proprietary Names
70
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- VIZOR ORTOPEDI MEDIKAL URUNLERI PAZARLAMA ITHALAT IHRACAT SANAYI VE TICARET LTD STI
- Registration Number
- 3033436414
- FEI Number
- 3033436414
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- K.3, NO:26B HALKALI MERKEZ MAHALLESI SEHIT ISMET CAVUS SOKAK DEREBOYU CADDESI,
- City
- KUCUKCEKMECE Istanbul
- Country
- TR
Owner / Operator
- Firm Name
- VIZOR ORTOPEDI MEDIKAL URUNLERI PAZARLAMA ITHALAT IHRACAT SA
- Operator Number
- 10091542
- Address
- K.3, NO:26B HALKALI MERKEZ MAHALLESI SEHIT ISMET CAVUS SOKAK DEREBOYU CADDESI,
- City
- KUCUKCEKMECE
- State
- Istanbul
- Postal Code
- 34303
- Country
- TR
- Correspondent
- Recep Bayrak
US Agent
- Business Name
- KAPLAN DISTRIBUTION LLC.
- Contact Name
- MEHMED UGUR
- Address
- 828 N Olden Ave Suite #4
- City
- Trenton
- State
- NJ
- ZIP
- 08638
- Country
- US
- [email protected]
- Phone
- 908 3138133
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2024-10-15 |
Proprietary Names
1004 FOOT GUARD
310 SILICONE INSOLE
604-ES AIRTEX HINGED KNEE SUPPORT
308 NEOPRENE SIMPLE WRISTBAND UNV
1001-J ANKLE BRACE WITH GEL
BF0005 FITTECH WRIST SPLINT (R/L) (Sizes S - XL)
5842 FITTECH STAR ANKLE SUPPORT (S-XL)
801 NEOPRENE THIGH SUPPORT
900-ES AIRTEX FLEXIBLE ANKLE SUPPORT
1001-P ANKLE BRACE WITH PAD
5840 FITTECH ANKLE SUPPORT (S-L)
901-ES AIRTEX CROSS ANKLE SUPPORT
601-ES AIRTEX SIMPLE KNEE SUPPORT
323 SILICONE TOE SPREADER
1002 R.O.M. WALKER (S-L)
300 SILICONE TOE RING
802-ES AIRTEX CALF SUPPORT
319 CORK INSOLE WITH CUSHIONING (NO:36 to 44)
1004-LUX LUX FOOT GUARD
321-E STARFLEX INSOLE WITH CUSHIONING (NO:36 to 44)
907 ELASTIC HALLUX VALGUS SPLINT (STANDARD)
311-C SILICONE HEEL COMFORT (S-L)
602-ES AIRTEX PATELLA KNEE SUPPORT
1000 DYNAMIC FOOT GUARD AFO
310-LUX SILICONE INSOLES FULL LENGTH
706 ACHILLES TENDON ANKLE SUPPORT (Sizes S - XXL)
313 SILICONE MEDIAL & LATERAL WEDGE(ADHESIVE)
325 SILICONE METATARSAL PAD WITH WEDGED (STANDARD)
704 WOVEN ANKLE SUPPORT
902-UNV NEOPRENE MALLEOLAR ANKLE SUPPORT (STANDARD)
326 SILICONE BUNION SHIELD (STANDARD)
321 STARFLEX INSOLE (NO:36 to 44)
1005 REFLEX AFO (R/L)
19-UNV STANDARD WRIST SPLINT
911 CAST SHOES (S-XL)
904 LACE-UP ANKLE SUPPORT
903 LIGAMENT ANKLE SUPPORT (S-XXL)
902 NEOPRENE MALLEOLAR ANKLE SUPPORT (Sizes S - XXL)
705 WOVEN MALLEOLAR ANKLE SUPPORT
903-ES AIRTEX LIGAMENT ANKLE SUPPORT
323-B SILICONE BUNION SHIELD AND TOE SPREADER
901 CROSS STRAP ANKLE SUPPORT (Sizes S - XXL)
BF0006 FITTECH STAR ANKLE SUPPORT (S-XL)
327 SILICONE HAMMER TOE CUSHION
318 CORK INSOLE (NO:36 to 44)
905 DORSIFLEXION BANDAGE
801-ES AIRTEX THIGH SUPPORT
BF0008 COMPREFLEX CALF TALL (S-XXL)
903-UNV NEOPRENE LIGAMENT ANKLE SUPPORT (STANDARD)
317 CALCANEUS HEEL SUPPORT (M-L)
7704 SPORT ANKLE SUPPORT (S-XXL)
1301 AIRTECH AIR WALKER (LONG) (S-L)
5819 FITTECH WRIST SPLINT (R/L) (Sizes S - XL)
604 STANDARD HINGED KNEE SUPPORT
906 HALLUX VALGUS NIGHT SPLINT (STANDARD) (R/L)
910 HALLUX VALGUS SHOES (S-XL)
21-ES AIRTEX WRIST SPLINT WITH THUMB SUPPORT
312 SILICONE INSOLE COVERED WITH FABRIC (XS-XXL)
603 STANDARD PATELLA AND LIGAMENT KNEE SUPPORT
309 NEOPRENE WRISTBAND
316 HEEL CUP (ADHESIVE)
324 SILICONE METATARSAL PAD WITH LOOP (STANDARD)
1001 ANKLE BRACE WITH AIR (AIR CAST) (STANDARD)
603-ES AIRTEX PATELLA AND LIGAMENT KNEE SUPPORT
315 SILICONE ARCH SUPPORT (ADHESIVE)
1300 AIRTECH AIR WALKER (SHORT) (S-L)
901-UNV NEOPRENE CROSS STRAP ANKLE SUPPORT (STANDARD)
1003 ACHILLES BOOT (S-L)
902-ES AIRTEX MALLEOLAR ANKLE SUPPORT
311 SILICONE HEEL CUP
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device