Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010884328

FEI Number

3010884328

Entity Name

SCOLICARE

City/State/Country

Kogarah New South Wales, AU

Establishment Address

Suite 5.08, Level 5, 15 Kensington Street, Kogarah New South Wales 2217, AU

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ScoliCare (Owner Number: 10055601)

Owner / Operator Contact Address

Suite 5.08, Level 5, 15 Kensington Street, Kogarah, AU-NSW 2217, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ScoliBrace KyphoBrace

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IPT	Orthosis, Thoracic	Physical Medicine	Class 1	890.3490	2017-08-21

Official Correspondent

Michelle McAviney

US Agent Details

Rachel Friddles-Johnson Email: rfjohnson@friddles.com Phone: (864) 2097291

Related Public Records

Same Entity

ScoliCare

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 3010884328. Last updated year: 2026. Please use registration number 3010884328 when referencing this establishment in official correspondence.