Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3029785246

FEI Number

3029785246

Entity Name

ORTHOTIC HOLDINGS INC.

City/State/Country

Mesa, AZ, US

Establishment Address

4825 East Ingram Street, Mesa, AZ 85205, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Orthotic Holdings Inc. (Owner Number: 10089075)

Owner / Operator Contact Address

4825 East Ingram Street, Mesa, AZ 85205, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Gaitscan Pedalign Digital Scanner Scan Cast 3D Roomy Socks Copper Cloud Langer Biomechanics - Custom Orthotics Apex - A-Wave SafeStep - Custom Diabetic Inserts Apex - Custom Diabetic Inserts Langer Biomechanics - Custom Diabetic Inserts Arizona AFO - Custom Ankle Foot Orthosis Brace Pedalign Holdings - Custom Orthotics Apex - Conform Insoles The Orthotic Group - Custom Orthotics Apex - Heat Molded Inserts APEX The Orthotic Group Footwear

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KHX	Platform, Force-Measuring	Physical Medicine	Class 1	890.1575	2023-11-03
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2023-12-06
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2023-11-03
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2023-12-06

Official Correspondent

Ashley Grode

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Orthotic Holdings Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014658359	MDI CORPORATION	Birmingham, AL, US
3006264697	The Orthotic Group Inc.	Markham Ontario, CA

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029785246. Last updated year: 2026. Please use registration number 3029785246 when referencing this establishment in official correspondence.