MACKWORTH USA, LLC.

FDA Device Registration & Listing · O Fallon, MO, US · Registration 3018050094

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3018050094
FEI Number
3018050094
Entity Name
MACKWORTH USA, LLC.
City/State/Country
O Fallon, MO, US
Establishment Address
54 W Industrial Dr, O Fallon, MO 63366, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Prism Medical UK (Owner Number: 10080006)
Owner / Operator Contact Address
Unit 4, Jubilee way, WAKEFIELD, GB-WKF WF4 4TD, GB
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Mackworth

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FSA Lift, Patient, Non-Ac-Powered General Hospital Class 1 880.5510 2021-01-07

Official Correspondent

Ian Morris

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Prism Medical UK
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3013318446 PRISM MEDICAL UK Rhyl Denbighshire, GB

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0013-2018 Handicare Usa Inc 1
PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
Z-0014-2018 Handicare AB Maskinvagen 1
Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018050094. Last updated year: 2026. Please use registration number 3018050094 when referencing this establishment in official correspondence.
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