Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1058311

FEI Number

1000307649

Entity Name

Blatchford, Inc.

City/State/Country

Miamisburg, OH, US

Establishment Address

1031 Byers Rd, Miamisburg, OH 45342, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Blatchford Inc dba Endolite. (Owner Number: 9011615)

Owner / Operator Contact Address

1031 Byers Rd, --, Miamisburg, OH 45342, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Blatchford Digital Health App - Tectus Tectus Orion Compact SAKL KX06 ESK+ Smart IP Aqualimb TF Orion 3 EUK 160H Linx BMK2 Mercury ESK+MKL Male Pyramid Adapter Proximal Adapter Non-Rotating Pyramid Adapter Avior Female Pyramid Adapter Avalon EchelonVT EliteVT Elan Multiflex ElanIC Dynamic Response 2 EchelonER Stellar Blade XT Aqualimb AvalonVAC Epirus EchelonVAC Multiflex Ankle TTPro Echelon Elite2 Mini Blade XT Javelin Super SACH Elite Blade Senior Navigator Elite BladeVT Esprit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2023-08-14
ISY	Joint, Knee, External Limb Component	Physical Medicine	Class 1	890.3420	1994-10-07
ISH	Component, External, Limb, Ankle/Foot	Physical Medicine	Class 1	890.3420	1994-10-07

Official Correspondent

Timothy Dues

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Blatchford Inc dba Endolite.

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 1058311. Last updated year: 2026. Please use registration number 1058311 when referencing this establishment in official correspondence.