Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1022826

FEI Number

1022826

Entity Name

FILLAUER, LLC

City/State/Country

CHATTANOOGA, TN, US

Establishment Address

2710 AMNICOLA HWY., CHATTANOOGA, TN 37406, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

FILLAUER COMPANIES, INC. (Owner Number: 9910012)

Owner / Operator Contact Address

2710 AMNICOLA HWY., Chattanooga, TN 37406, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PTB Cuff Suspension Pelvic Band and Belt Pelvic Support Drop Lock Steplock Interlock 2400 Joints Cam Lock MightyMite Components Shuttle Lock Endoskeletal Alignment System ALP adaptors Clutch Lock AP&ML Unit Gator Grip Wrist Lock Structural Components Prosthetic Alignment Devices Hand Shell Footshell NEO Axilla Loop Padding Procover Arm Skinz Foam Cover Dreamskin Natural Definition cosmetic gloves and covers Absolute Sleeve Omega Prosthetic Wrists and Arm Frames Prosthetic cable components and accessories Night Splint Denis Browne Splint Mechanical Hands Passive Hands Prosthetic Recreational Terminal Devices Element K2 Formula SLX Foot Wave El Dorado Climbing Foot AllPro Little Feet Ibex Aeris MX Foot Obsidian Prosthetic Hooks ADEPT Grip JAWS Sargent Roy Hip Joint PDC Orthotic External Ankle Joints Spring Wire Orthosis PDA Hip Dislocation Abduction Splint Abduction Orthosis Scottish Rite Pavlik Harness WALK SAFK Endurance TFR SPK SALK Procuff Arm Frames EZ Arm BE Cuffs

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2001-06-01
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2001-06-01
IQO	Device, Prosthesis Alignment	Physical Medicine	Class 1	890.3025	2003-04-09
IPM	Cover, Limb	Physical Medicine	Class 1	890.3025	2003-04-09
ISZ	Unit, Wrist, External Limb Component, Mechanical	Physical Medicine	Class 1	890.3420	1998-11-30
ISN	Cable	Physical Medicine	Class 1	890.3420	2023-09-27
ITN	Splint, Denis Brown	Physical Medicine	Class 1	890.3675	1992-08-05
IRA	Hand, External Limb Component, Mechanical	Physical Medicine	Class 1	890.3420	2002-05-31
ISH	Component, External, Limb, Ankle/Foot	Physical Medicine	Class 1	890.3420	2004-04-21
IQX	Hook, External Limb Component, Mechanical	Physical Medicine	Class 1	890.3420	1998-07-22
ISL	Joint, Hip, External Limb Component	Physical Medicine	Class 1	890.3420	1998-11-30
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	1998-11-30
IOZ	Splint, Abduction, Congenital Hip Dislocation	Physical Medicine	Class 1	890.3665	1992-08-05
ISY	Joint, Knee, External Limb Component	Physical Medicine	Class 1	890.3420	2001-06-01
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2023-09-27

Official Correspondent

Annette Cole

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

FILLAUER COMPANIES, 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
1723997	MOTION CONTROL, INC.	SALT LAKE CITY, UT, US
9681133	FILLAUER EUROPE	JARFALLA Stockholm, SE
3007510149	Fillauer Composites	Salt Lake City, UT, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1022826. Last updated year: 2026. Please use registration number 1022826 when referencing this establishment in official correspondence.