Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007853907

FEI Number

3007853907

Entity Name

PROMEDICS ORTHOPAEDIC LTD

City/State/Country

Port Glasgow Scotland, GB

Establishment Address

Port Glasgow Ind Est, Gareloch Road, Port Glasgow Scotland PA14 5XH, GB

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Promedics Orthopaedic Ltd (Owner Number: 10034658)

Owner / Operator Contact Address

Port Glasgow Ind Est, Gareloch Road, Port Glasgow, GB-SCT PA14 5XH, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pro Tem Belt Maternity Support ProForm Back Support Hernia Belt Fixstep Lacer UNIVERSAL PLANTAR FASCIITIS ORTHOSIS Clavicle Splint Delta & Freedom Liberty Abdominal Binder Ascender Post-Op ROM Knee Brace Lancaster Shoulder Sling Jura Wrist Thumb Brace Jura Thumb Brace Ascender Elbow Brace Jura Three Panel Immobilizer Jura Resting Splint Paladin XT JURA ABDUCTION SLING

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2023-02-13
EXN	Support, Hernia	Gastroenterology, Urology	Class 1	876.5970	2023-02-13
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2024-08-28
IQJ	Splint, Clavicle	Physical Medicine	Class 1	890.3490	2023-02-13
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2010-12-20
FSD	Binder, Abdominal	General Hospital	Class 1	880.5160	2023-02-13
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2021-11-13

Official Correspondent

No official correspondent registered.

US Agent Details

John Hamilton Email: jhamilton@aspenmp.com Phone: (949) 6810200

Related Public Records

Same Entity

Promedics Orthopaedic Ltd

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 3007853907. Last updated year: 2026. Please use registration number 3007853907 when referencing this establishment in official correspondence.