Medifab

FDA Filings

This page includes the latest FDA filings for Medifab. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3012958676
FEI Number3012958676
NameMEDIFAB
Owner & OperatorMedifab
Contact Address32 Detroit Drive
Rolleston NZ-NOTA 7675 NZ
Official Correspondent
  • David Rothkopf
  • 64-3-3079790-x
US Agent
Importing Logistics Registration
ImporterMedifab Limited Partnership
Address9814 Richlyn Drive
Perry Hall, MD 21128 UNITED STATES
Importer TypeAgent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address32 Detroit Drive
Rolleston Canterbury, 7675 NZ
Establishment Type
  • Manufacture Medical Device
  • Export Device to the United States But Perform No Other Operation on Device



FDA Filings

Device
Company
DeviceDate
MEDIFAB
Seahorse Plus Toileting & Shower Chair S2018-08-22
MEDIFAB
Seahorse Plus Toileting & Shower Chair M2018-08-22
MEDIFAB
Seahorse Plus Toileting & Shower Chair L2018-08-22
MEDIFAB
Seahorse Plus Small Liner, Size 1 (Thick)2018-08-22
MEDIFAB
Seahorse Plus Small Liner Size 2 (Thin)2018-08-22
MEDIFAB
Seahorse Plus Medium Liner Size 4 (Thin)2018-08-22
MEDIFAB
Seahorse Plus Medium Liner Size 3, Thick2018-08-22
MEDIFAB
Seahorse Plus Large Liner Size 6 (Thin)2018-08-22
MEDIFAB
Seahorse Plus Large Liner Size 5 (Thick)2018-08-22
MEDIFAB
Seahorse Plus Chest Harness-Small2018-08-22
MEDIFAB
Seahorse Plus Chest Harness-Med2018-08-22
MEDIFAB
Seahorse Plus Chest Harness-Large2018-08-22
MEDIFAB
Seahorse Plus Butterfly Harness-Small2018-08-22
MEDIFAB
Seahorse Plus Butterfly Harness-Med2018-08-22
MEDIFAB
Seahorse Plus Butterfly Harness-Large2018-08-22
MEDIFAB
Seahorse Plus Armrests2018-08-22
MEDIFAB
Seahorse Plus Anterior Support, Med & Lg2018-08-22
MEDIFAB
Seahorse Plus Anterior Support - Small2018-08-22
MEDIFAB
Medifab Poz'n'Form Kit2018-08-22
MEDIFAB
Medifab Poz'n'Form Cushion2018-08-22
MEDIFAB
Medifab Leg Cushion2018-08-22
MEDIFAB
Medifab Kid'n'Form Kit2018-08-22
MEDIFAB
Medifab Kid'n'Form Cushion2018-08-22
MEDIFAB
Medifab CareWave Kit2018-08-22
MEDIFAB
Medifab CareWave Cushion2018-08-22
MEDIFAB
Medifab CareWave Cover2018-08-22
MEDIFAB
Neat Zeat Mobile Base2016-12-05
MEDIFAB
Medifab Gravity positioning Chair2016-12-05
MEDIFAB
Medifab Gravity Chair wipe down cover set2016-12-05
MEDIFAB
Medifab Gravity Chair air flow cover set2016-12-05
MEDIFAB
Medifab Gravity Chair Therapy tray2016-12-05
MEDIFAB
Gravity Chair Seat Liner2016-12-05
MEDIFAB
Gravity Chair Push Handle2016-12-05
MEDIFAB
Gravity Chair Mobile Base2016-12-05
MEDIFAB
Gravity Chair Incontinence liner2016-12-05
MEDIFAB
Gravity Chair Hip Belt2016-12-05
MEDIFAB
Gravity Chair Headrest2016-12-05
MEDIFAB
Discovery Seat with Launcher Base2016-12-05
MEDIFAB
Wonderseat Arm Support2016-11-02
MEDIFAB
Forearm Supports2016-11-02
MEDIFAB
Tray Tables2016-11-02
MEDIFAB
Wonderseat Lateral Trunk Support2016-11-02
MEDIFAB
Wonderseat Lateral Adductor Support2016-11-02
MEDIFAB
Wonderseat Head Support2016-11-02
MEDIFAB
Medifab Josi Octopus2016-11-02
MEDIFAB
Medial Knee Support2016-11-02
MEDIFAB
Lateral Trunk Supports2016-11-02
MEDIFAB
Head Supports2016-11-02
MEDIFAB
Wonderseat Seat Cushion2016-11-02
MEDIFAB
Cushions2016-11-02
MEDIFAB
Wonderseat Axial Pelvic2016-11-02
MEDIFAB
Upper & Lower Limb Stabilisers2016-11-02
MEDIFAB
Trunk Positioning2016-11-02
MEDIFAB
Pelvic Positioning2016-11-02
MEDIFAB
Pelvi-Loc2016-11-02
MEDIFAB
Pelvi-Loc padding upgrade2016-11-02
MEDIFAB
Medifab Harness/ Hip Belt Accessories2016-11-02
MEDIFAB
Wonderseat Axial Pelvic2016-10-31
MEDIFAB
Velcro Foot Straps2016-10-31
MEDIFAB
Trochanter Wedges on Velcro Attachment2016-10-31
MEDIFAB
Thigh Wedges on Velcro Attachment2016-10-31
MEDIFAB
Thigh Adduction Guides Jet Black - Width, Angle and Depth Adjustment2016-10-31
MEDIFAB
Thigh Adduction Guides Ink Black - Width, Angle and Depth Adjustment2016-10-31
MEDIFAB
Sternum Harness2016-10-31
MEDIFAB
Snuggle Warmer2016-10-31
MEDIFAB
Shoulder Protraction Wedge on Velcro Attachment2016-10-31
MEDIFAB
Shoulder / Crotch Strap Set2016-10-31
MEDIFAB
Seat Canopy including mounts2016-10-31
MEDIFAB
Sacral Foam Insert on Velcro Attachment2016-10-31
MEDIFAB
Rain Cover Single2016-10-31
MEDIFAB
Rain Cover Double2016-10-31
MEDIFAB
Quick Release Grab Rail for Tray2016-10-31
MEDIFAB
Padded Tray Top, Zip-on, Wipe-down Cover2016-10-31
MEDIFAB
Padded Ankle Wrap2016-10-31
MEDIFAB
Oxygen Bottle Holder2016-10-31
MEDIFAB
Ocean Padding - Seat Cushion, Backrest Cushion, Backrest wings, Seat and footplate calf pad2016-10-31
MEDIFAB
Ocean - Modular seat cushion upgrade2016-10-31
MEDIFAB
Mango Padding - Seat Cushion, Backrest Cushion, Backrest wings, Seat and footplate calf pad2016-10-31
MEDIFAB
Mango - Modular seat cushion upgrade2016-10-31
MEDIFAB
Lateral Adductor supports2016-10-31
MEDIFAB
Jet Black Padding - Seat Cushion, Backrest Cushion, Backrest wings, Seat and footplate calf pad2016-10-31
MEDIFAB
Jet Black - Modular seat cushion upgrade2016-10-31
MEDIFAB
Ink Black Padding - Seat Cushion, Backrest Cushion, Backrest wings, Seat and footplate calf pad2016-10-31
MEDIFAB
Ink Black - Modular seat cushion upgrade2016-10-31
MEDIFAB
Independent Hip Guide Mounting Bracket2016-10-31
MEDIFAB
Hip Guides Jet Black - Width, Angle and Depth Adjustable2016-10-31
MEDIFAB
Hip Guides Ink Black - Width, Angle and Depth Adjustable2016-10-31
MEDIFAB
Height, Depth, Angle Adjustable Tray with seat pan tray mount brackets2016-10-31
MEDIFAB
Footplate Over-Cover in Neoprene2016-10-31
MEDIFAB
Footplate Neoprene Protection Cover Std2016-10-31
MEDIFAB
Footplate Neoprene Protection Cover Ext2016-10-31
MEDIFAB
Footplate Extension2016-10-31
MEDIFAB
Foam Spacer to adhere behind primary Sacral Insert2016-10-31
MEDIFAB
Dorsiflection Wedge in closed cell foam Velcro attached to footplate2016-10-31
MEDIFAB
Critical Care Basket2016-10-31
MEDIFAB
CentrePoint Harness, X-Small2016-10-31
MEDIFAB
Calypso Padding - Seat Cushion, Backrest Cushion, Backrest wings, Seat and footplate calf pad2016-10-31
MEDIFAB
Calypso - Modular seat cushion upgrade2016-10-31
MEDIFAB
Abductor Pommel Jet Black - Quick Release2016-10-31
MEDIFAB
Abductor Pommel Ink Black - Quick Release2016-10-31
MEDIFAB
5 Point Harness with 5 Way Buckle, Jet, Breathable2016-10-31
MEDIFAB
5 Point Harness with 5 Way Buckle, Ink, wipe-down2016-10-31
MEDIFAB
5 Point Harness on Tee Pad2016-10-31
MEDIFAB
4 Point Hip Belt, X-Small2016-10-31
MEDIFAB
2 Point Hip Belt2016-10-31
MEDIFAB
1/2 inch Soft Sunmate Foam Overlay2016-10-31
MEDIFAB
Wonderseat Backrest2016-10-31
MEDIFAB
Tear Drop Size 2 Thoracic Jet Black2016-10-31
MEDIFAB
Tear Drop Size 2 Thoracic Ink Black2016-10-31
MEDIFAB
Tear Drop Size 1 Thoracic Jet Black2016-10-31
MEDIFAB
Tear Drop Size 1 Thoracic Ink Black2016-10-31
MEDIFAB
Seatpans2016-10-31
MEDIFAB
Occipital Headrest Jet Black2016-10-31
MEDIFAB
Occipital Headrest Ink Black2016-10-31
MEDIFAB
Headrest Wide: Standard Jet Black2016-10-31
MEDIFAB
Headrest Wide: Standard Ink Black2016-10-31
MEDIFAB
Headrest Wide: Extended Jet Black2016-10-31
MEDIFAB
Headrest Wide: Extended Ink Black2016-10-31
MEDIFAB
Headrest Laterals Jet Black2016-10-31
MEDIFAB
Headrest Laterals Ink Black2016-10-31
MEDIFAB
Contoured Thoracic Jet Black2016-10-31
MEDIFAB
Contoured Thoracic Ink Black2016-10-31
MEDIFAB
Caster Wheel2016-10-31
MEDIFAB
Backrests2016-10-31
MEDIFAB
Neat Zeat Chair2016-10-31
MEDIFAB
Discovery Seat with Moon Rock Base2016-10-31
MEDIFAB
Discovery Seat with Lunar Base2016-10-31

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