Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012958676

FEI Number

3012958676

Entity Name

Spex Ltd

City/State/Country

Rolleston Canterbury, NZ

Establishment Address

1 Pereita Drive, Rolleston Canterbury 7614, NZ

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Medifab (Owner Number: 10053091)

Owner / Operator Contact Address

1 Pereita Drive, Rolleston, NZ-NOTA 7614, NZ

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Wonderseat Seating System Spex Forearm Straps Wonderseat Hip Belt Spex Hip Belt Spex Ankle Stabilisers Spex Chest Strap Spex Calf Supports Wonderseat Harness Spex Harness Spex Cushion Base Spex for Bingo Cushion Wonderseat Cushion Spec Cushion Spex Lateral Trunk Support Spex Head Support Pad Spex for Bingo Head Support Hardware Spex Lateral Trunk Support Hardware Spex Head Support Hardware Wonderseat Head Support Hardware Spex for Bingo Lateral Trunk Support Spex for Bingo Pelvic Support Spex Arm Support Pad Spex Back Support Hardware Wonderseat Arm Support Pad Wonderseat Seating System Part Pod Spex Seat Base Spex Lateral Thigh Support Hardware Spex Back Support Arm and Thigh Combo Wonderseat Medial Thigh Support Spex Wheelchair Padding Wonderseat Arm and Thigh Support Hardware Spex Lateral Thigh Support Pad Zygo Back Support Spex for Bingo Back Support Spex Medial Thigh Support Spex for Bingo Arm Support Wonderseat Tray Tables Spex Soft Padded Tray

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KNO	Accessories, Wheelchair	Physical Medicine	Class 1	890.3910	2016-10-31
IMP	Cushion, Wheelchair	Physical Medicine	Class 1	890.3920	2016-11-02
IMS	Support, Head And Trunk, Wheelchair	Physical Medicine	Class 1	890.3910	2016-11-02
KNN	Components, Wheelchair	Physical Medicine	Class 1	890.3920	2016-10-31
IMX	Board, Lap, Wheelchair	Physical Medicine	Class 1	890.3910	2016-11-02

Official Correspondent

No official correspondent registered.

US Agent Details

David Rothkopf Email: drothkopf@medicept.com Phone: (617) 8993449

Related Public Records

Same Entity

Medifab

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012958676. Last updated year: 2026. Please use registration number 3012958676 when referencing this establishment in official correspondence.