Fillauer Companies Inc

FDA Filings

This page includes the latest FDA filings for Fillauer Companies Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 9681133
• FEI Number: 3005564811
• Name: FILLAUER EUROPE
• Owner & Operator: FILLAUER COMPANIES, INC.
• Contact Address: 2710 AMNICOLA HWY. P.O. BOX 5189; Chattanooga TN 37406 US
• Official Correspondent:
  • Sheri P Hassler
  • x-423-6240946-x
• US Agent:
  • SHERI HASSLER
  • FILLAUER LLC
  • 423 6240946 290
  • 423 6227631
  • shassler@fillauer.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: KUNG HANS VAG 2 192 68 SOLLENTUNA; JARFALLA Stockholms lan [SE-01], -- SE
• Establishment Type: Manufacture Medical Device

• Registration Number: 1723997
• FEI Number: 3001237006
• Name: MOTION CONTROL, INC.
• Owner & Operator: FILLAUER COMPANIES, INC.
• Contact Address: 2710 AMNICOLA HWY. P.O. BOX 5189; Chattanooga TN 37406 US
• Official Correspondent:
  • Sheri P Hassler
  • x-423-6240946-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 115 N WRIGHT BROTHERS DR ; SALT LAKE CITY, UT 84116 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 1022826
• FEI Number: 1022826
• Name: FILLAUER, LLC
• Owner & Operator: FILLAUER COMPANIES, INC.
• Contact Address: 2710 AMNICOLA HWY. P.O. BOX 5189; Chattanooga TN 37406 US
• Official Correspondent:
  • Sheri P Hassler
  • x-423-6240946-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 2710 AMNICOLA HWY. ; CHATTANOOGA, TN 37406 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 1718966
• FEI Number: 1718966
• Name: THERAPEUTIC RECREATION SYSTEMS, INC.
• Owner & Operator: FILLAUER COMPANIES, INC.
• Contact Address: 2710 AMNICOLA HWY. P.O. BOX 5189; Chattanooga TN 37406 US
• Official Correspondent:
  • Sheri P Hassler
  • x-423-6240946-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 3090 STERLING CIR., STUDIO A ; BOULDER, CO 80301 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 1036132
• FEI Number: 1036132
• Name: FILLAUER NORTH CAROLINA
• Owner & Operator: FILLAUER COMPANIES, INC.
• Contact Address: 2710 AMNICOLA HWY. P.O. BOX 5189; Chattanooga TN 37406 US
• Official Correspondent:
  • Sheri P Hassler
  • x-423-6240946-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 220 MERRIMON AVE ; WEAVERVILLE, NC 28787 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
ISP FILLAUER, LLC [FILLAUER COMPANIES, INC.]	VALVE	2004-04-21
ISP FILLAUER, LLC [FILLAUER COMPANIES, INC.]	PROSTHESIS	2004-04-21
ISP FILLAUER EUROPE [FILLAUER COMPANIES, INC.]	VALVE	2004-04-21
ISP FILLAUER EUROPE [FILLAUER COMPANIES, INC.]	PROSTHESIS	2004-04-21
ISH THERAPEUTIC RECREATION SYSTEMS, INC. [FILLAUER COMPANIES, INC.]	WAVE	2004-04-21
ISH THERAPEUTIC RECREATION SYSTEMS, INC. [FILLAUER COMPANIES, INC.]	Raize	2004-04-21
ISH THERAPEUTIC RECREATION SYSTEMS, INC. [FILLAUER COMPANIES, INC.]	MOTION FOOT	2004-04-21
ISH THERAPEUTIC RECREATION SYSTEMS, INC. [FILLAUER COMPANIES, INC.]	MOTION FOOT MX	2004-04-21
ISH THERAPEUTIC RECREATION SYSTEMS, INC. [FILLAUER COMPANIES, INC.]	IBEX	2004-04-21
ISH THERAPEUTIC RECREATION SYSTEMS, INC. [FILLAUER COMPANIES, INC.]	ELEMENT	2004-04-21
ISH THERAPEUTIC RECREATION SYSTEMS, INC. [FILLAUER COMPANIES, INC.]	AERIS	2004-04-21
ISH MOTION CONTROL, INC. [FILLAUER COMPANIES, INC.]	WAVE	2004-04-21
ISH MOTION CONTROL, INC. [FILLAUER COMPANIES, INC.]	Raize	2004-04-21
ISH MOTION CONTROL, INC. [FILLAUER COMPANIES, INC.]	MOTION FOOT	2004-04-21
ISH MOTION CONTROL, INC. [FILLAUER COMPANIES, INC.]	MOTION FOOT MX	2004-04-21
ISH MOTION CONTROL, INC. [FILLAUER COMPANIES, INC.]	IBEX	2004-04-21
ISH MOTION CONTROL, INC. [FILLAUER COMPANIES, INC.]	ELEMENT	2004-04-21
ISH MOTION CONTROL, INC. [FILLAUER COMPANIES, INC.]	AERIS	2004-04-21
ISH FILLAUER, LLC [FILLAUER COMPANIES, INC.]	WAVE	2004-04-21
ISH FILLAUER, LLC [FILLAUER COMPANIES, INC.]	Raize	2004-04-21
ISH FILLAUER, LLC [FILLAUER COMPANIES, INC.]	MOTION FOOT	2004-04-21
ISH FILLAUER, LLC [FILLAUER COMPANIES, INC.]	MOTION FOOT MX	2004-04-21
ISH FILLAUER, LLC [FILLAUER COMPANIES, INC.]	IBEX	2004-04-21
ISH FILLAUER, LLC [FILLAUER COMPANIES, INC.]	ELEMENT	2004-04-21
ISH FILLAUER, LLC [FILLAUER COMPANIES, INC.]	AERIS	2004-04-21
GBI FILLAUER EUROPE [FILLAUER COMPANIES, INC.]	VARIOUS COSMETIC BODY RESTORATIONS	2004-04-21
IQO FILLAUER, LLC [FILLAUER COMPANIES, INC.]	PROSTHETIC ALIGNMENT DEVICE	2003-04-09
IQO FILLAUER, LLC [FILLAUER COMPANIES, INC.]	ENDOSKELETAL ALIGNMENT SYSTEM	2003-04-09
IQO FILLAUER EUROPE [FILLAUER COMPANIES, INC.]	PROSTHETIC ALIGNMENT DEVICE	2003-04-09
IQO FILLAUER EUROPE [FILLAUER COMPANIES, INC.]	ENDOSKELETAL ALIGNMENT SYSTEM	2003-04-09
IPM FILLAUER, LLC [FILLAUER COMPANIES, INC.]	LIMB	2003-04-09
IPM FILLAUER, LLC [FILLAUER COMPANIES, INC.]	GLOVES	2003-04-09
IPM FILLAUER, LLC [FILLAUER COMPANIES, INC.]	DREAMSKIN	2003-04-09
IPM FILLAUER, LLC [FILLAUER COMPANIES, INC.]	ABSOLUTE SLEEVE	2003-04-09
IPM FILLAUER, LLC [FILLAUER COMPANIES, INC.]	ABSOLUTE LINER	2003-04-09
IPM FILLAUER EUROPE [FILLAUER COMPANIES, INC.]	LIMB	2003-04-09
IPM FILLAUER EUROPE [FILLAUER COMPANIES, INC.]	GLOVES	2003-04-09
IPM FILLAUER EUROPE [FILLAUER COMPANIES, INC.]	DREAMSKIN	2003-04-09
IPM FILLAUER EUROPE [FILLAUER COMPANIES, INC.]	ABSOLUTE SLEEVE	2003-04-09
IPM FILLAUER EUROPE [FILLAUER COMPANIES, INC.]	ABSOLUTE LINER	2003-04-09
IRA THERAPEUTIC RECREATION SYSTEMS, INC. [FILLAUER COMPANIES, INC.]	CENTRI AB HANDS	2002-05-31
IRA FILLAUER, LLC [FILLAUER COMPANIES, INC.]	CENTRI AB HANDS	2002-05-31
IRA FILLAUER EUROPE [FILLAUER COMPANIES, INC.]	CENTRI AB HANDS	2002-05-31
ITQ FILLAUER, LLC [FILLAUER COMPANIES, INC.]	STEPLOCK	2001-06-01
ITQ FILLAUER, LLC [FILLAUER COMPANIES, INC.]	KAFO DROP LOCK KNE	2001-06-01
ITQ FILLAUER, LLC [FILLAUER COMPANIES, INC.]	INTERLOCK	2001-06-01
ITQ FILLAUER, LLC [FILLAUER COMPANIES, INC.]	EXTERNAL BRACE	2001-06-01
ITQ FILLAUER NORTH CAROLINA [FILLAUER COMPANIES, INC.]	STEPLOCK	2001-06-01
ITQ FILLAUER NORTH CAROLINA [FILLAUER COMPANIES, INC.]	KAFO DROP LOCK KNE	2001-06-01
ITQ FILLAUER NORTH CAROLINA [FILLAUER COMPANIES, INC.]	INTERLOCK	2001-06-01
ITQ FILLAUER NORTH CAROLINA [FILLAUER COMPANIES, INC.]	EXTERNAL BRACE	2001-06-01
ITC FILLAUER, LLC [FILLAUER COMPANIES, INC.]	STIRRUP	2001-06-01
ITC FILLAUER, LLC [FILLAUER COMPANIES, INC.]	EXTERNAL BRACE COMPONENT	2001-06-01
ISY FILLAUER, LLC [FILLAUER COMPANIES, INC.]	WALK	2001-06-01
ISR FILLAUER, LLC [FILLAUER COMPANIES, INC.]	PELVIC SUPPORT	2001-06-01
ISR FILLAUER, LLC [FILLAUER COMPANIES, INC.]	BAND OR BELT	2001-06-01
IQK FILLAUER, LLC [FILLAUER COMPANIES, INC.]	CERVICAL	2001-06-01
IPT FILLAUER, LLC [FILLAUER COMPANIES, INC.]	THORACIC	2001-06-01
IRE MOTION CONTROL, INC. [FILLAUER COMPANIES, INC.]	UTAH ARM	1998-12-07
IRE MOTION CONTROL, INC. [FILLAUER COMPANIES, INC.]	E2 ELBOW	1998-12-07
IRE FILLAUER, LLC [FILLAUER COMPANIES, INC.]	UTAH ARM	1998-12-07
IRE FILLAUER, LLC [FILLAUER COMPANIES, INC.]	E2 ELBOW	1998-12-07
ITW FILLAUER, LLC [FILLAUER COMPANIES, INC.]	DYNAMIC WALK	1998-11-30
ITW FILLAUER EUROPE [FILLAUER COMPANIES, INC.]	DYNAMIC WALK	1998-11-30
ITS FILLAUER, LLC [FILLAUER COMPANIES, INC.]	Post op Total Hip Orthotic Joint	1998-11-30
ISZ THERAPEUTIC RECREATION SYSTEMS, INC. [FILLAUER COMPANIES, INC.]	FM Quick change wrist	1998-11-30
ISZ FILLAUER, LLC [FILLAUER COMPANIES, INC.]	FM Quick change wrist	1998-11-30
IRD FILLAUER, LLC [FILLAUER COMPANIES, INC.]	E-400 Elbow	1998-11-30
IQX THERAPEUTIC RECREATION SYSTEMS, INC. [FILLAUER COMPANIES, INC.]	HOSMER TERMINAL DEVICE	1998-07-22
IQX THERAPEUTIC RECREATION SYSTEMS, INC. [FILLAUER COMPANIES, INC.]	HOSMER HOOK	1998-07-22
IQX THERAPEUTIC RECREATION SYSTEMS, INC. [FILLAUER COMPANIES, INC.]	Grip	1998-07-22
IQX THERAPEUTIC RECREATION SYSTEMS, INC. [FILLAUER COMPANIES, INC.]	ADEPT	1998-07-22
IQX FILLAUER, LLC [FILLAUER COMPANIES, INC.]	HOSMER TERMINAL DEVICE	1998-07-22
IQX FILLAUER, LLC [FILLAUER COMPANIES, INC.]	HOSMER HOOK	1998-07-22
IQX FILLAUER, LLC [FILLAUER COMPANIES, INC.]	Grip	1998-07-22
IQX FILLAUER, LLC [FILLAUER COMPANIES, INC.]	ADEPT	1998-07-22
IQZ MOTION CONTROL, INC. [FILLAUER COMPANIES, INC.]	PROCONTROL 2	1997-08-20
IQZ MOTION CONTROL, INC. [FILLAUER COMPANIES, INC.]	MOTION CONTROL WRIST	1997-08-20
IQZ MOTION CONTROL, INC. [FILLAUER COMPANIES, INC.]	MOTION CONTROL HAND	1997-08-20
IQZ MOTION CONTROL, INC. [FILLAUER COMPANIES, INC.]	ETD2	1997-08-20
IQZ MOTION CONTROL, INC. [FILLAUER COMPANIES, INC.]	ELECTRIC TERMINAL DEVICE (ETD)	1997-08-20
HCC MOTION CONTROL, INC. [FILLAUER COMPANIES, INC.]	MYOLAB II	1997-08-08
IQQ FILLAUER, LLC [FILLAUER COMPANIES, INC.]	AXILLA PAD	1994-09-21
ITN FILLAUER, LLC [FILLAUER COMPANIES, INC.]	FILLAUER NIGHT SPLINT	1992-08-05
ITN FILLAUER, LLC [FILLAUER COMPANIES, INC.]	FILLAUER DETACHABLE NIGHT SPLINT	1992-08-05
IQI FILLAUER, LLC [FILLAUER COMPANIES, INC.]	VON ROSEN SPLINT	1992-08-05
IQI FILLAUER, LLC [FILLAUER COMPANIES, INC.]	TUBE	1992-08-05
IQI FILLAUER, LLC [FILLAUER COMPANIES, INC.]	TRILATERAL KIT	1992-08-05
IQI FILLAUER, LLC [FILLAUER COMPANIES, INC.]	TORONTO KIT	1992-08-05
IQI FILLAUER, LLC [FILLAUER COMPANIES, INC.]	STEPLOCK	1992-08-05
IQI FILLAUER, LLC [FILLAUER COMPANIES, INC.]	STANDING FRAME	1992-08-05
IQI FILLAUER, LLC [FILLAUER COMPANIES, INC.]	SPRING WIRE DORSI FL	1992-08-05
IQI FILLAUER, LLC [FILLAUER COMPANIES, INC.]	SPIRAL AFO KIT	1992-08-05
IQI FILLAUER, LLC [FILLAUER COMPANIES, INC.]	SCOTTISH RITE KIT WITH SPREADER BAR	1992-08-05
IQI FILLAUER, LLC [FILLAUER COMPANIES, INC.]	SCOTTISH RITE KIT W	1992-08-05
IQI FILLAUER, LLC [FILLAUER COMPANIES, INC.]	RECIPROCATOR KIT	1992-08-05
IQI FILLAUER, LLC [FILLAUER COMPANIES, INC.]	POSTERIOR LEAF SPRING ORTHOLEN	1992-08-05
IQI FILLAUER, LLC [FILLAUER COMPANIES, INC.]	PELVIC BAND WITH HIP JOINT	1992-08-05
IQI FILLAUER, LLC [FILLAUER COMPANIES, INC.]	PAVLIK HARNESS	1992-08-05
IQI FILLAUER, LLC [FILLAUER COMPANIES, INC.]	INSERT	1992-08-05
IQI FILLAUER, LLC [FILLAUER COMPANIES, INC.]	HEMI SPIRAL AFO KIT	1992-08-05
IQI FILLAUER, LLC [FILLAUER COMPANIES, INC.]	HARVEY ARM ABDUCTION ORTHOSIS	1992-08-05
IQI FILLAUER, LLC [FILLAUER COMPANIES, INC.]	FOOT ORTHOTICS	1992-08-05
IQI FILLAUER, LLC [FILLAUER COMPANIES, INC.]	FILLAUER NIGHT SPLINT	1992-08-05
IQI FILLAUER, LLC [FILLAUER COMPANIES, INC.]	ANKLE JOINT ASSEMBLY	1992-08-05
IQI FILLAUER, LLC [FILLAUER COMPANIES, INC.]	ABDUCTION ORTHOSIS	1992-08-05
IQI FILLAUER, LLC [FILLAUER COMPANIES, INC.]	A FRAME ORTHOSIS	1992-08-05
IQI FILLAUER NORTH CAROLINA [FILLAUER COMPANIES, INC.]	VON ROSEN SPLINT	1992-08-05
IQI FILLAUER NORTH CAROLINA [FILLAUER COMPANIES, INC.]	TUBE	1992-08-05
IQI FILLAUER NORTH CAROLINA [FILLAUER COMPANIES, INC.]	TRILATERAL KIT	1992-08-05
IQI FILLAUER NORTH CAROLINA [FILLAUER COMPANIES, INC.]	TORONTO KIT	1992-08-05
IQI FILLAUER NORTH CAROLINA [FILLAUER COMPANIES, INC.]	STEPLOCK	1992-08-05
IQI FILLAUER NORTH CAROLINA [FILLAUER COMPANIES, INC.]	STANDING FRAME	1992-08-05
IQI FILLAUER NORTH CAROLINA [FILLAUER COMPANIES, INC.]	SPRING WIRE DORSI FL	1992-08-05
IQI FILLAUER NORTH CAROLINA [FILLAUER COMPANIES, INC.]	SPIRAL AFO KIT	1992-08-05
IQI FILLAUER NORTH CAROLINA [FILLAUER COMPANIES, INC.]	SCOTTISH RITE KIT WITH SPREADER BAR	1992-08-05
IQI FILLAUER NORTH CAROLINA [FILLAUER COMPANIES, INC.]	SCOTTISH RITE KIT W	1992-08-05
IQI FILLAUER NORTH CAROLINA [FILLAUER COMPANIES, INC.]	RECIPROCATOR KIT	1992-08-05
IQI FILLAUER NORTH CAROLINA [FILLAUER COMPANIES, INC.]	POSTERIOR LEAF SPRING ORTHOLEN	1992-08-05
IQI FILLAUER NORTH CAROLINA [FILLAUER COMPANIES, INC.]	PELVIC BAND WITH HIP JOINT	1992-08-05
IQI FILLAUER NORTH CAROLINA [FILLAUER COMPANIES, INC.]	PAVLIK HARNESS	1992-08-05
IQI FILLAUER NORTH CAROLINA [FILLAUER COMPANIES, INC.]	INSERT	1992-08-05
IQI FILLAUER NORTH CAROLINA [FILLAUER COMPANIES, INC.]	HEMI SPIRAL AFO KIT	1992-08-05
IQI FILLAUER NORTH CAROLINA [FILLAUER COMPANIES, INC.]	HARVEY ARM ABDUCTION ORTHOSIS	1992-08-05
IQI FILLAUER NORTH CAROLINA [FILLAUER COMPANIES, INC.]	FOOT ORTHOTICS	1992-08-05
IQI FILLAUER NORTH CAROLINA [FILLAUER COMPANIES, INC.]	FILLAUER NIGHT SPLINT	1992-08-05
IQI FILLAUER NORTH CAROLINA [FILLAUER COMPANIES, INC.]	ANKLE JOINT ASSEMBLY	1992-08-05
IQI FILLAUER NORTH CAROLINA [FILLAUER COMPANIES, INC.]	ABDUCTION ORTHOSIS	1992-08-05
IQI FILLAUER NORTH CAROLINA [FILLAUER COMPANIES, INC.]	A FRAME ORTHOSIS	1992-08-05
IQI FILLAUER EUROPE [FILLAUER COMPANIES, INC.]	VON ROSEN SPLINT	1992-08-05
IQI FILLAUER EUROPE [FILLAUER COMPANIES, INC.]	TUBE	1992-08-05
IQI FILLAUER EUROPE [FILLAUER COMPANIES, INC.]	TRILATERAL KIT	1992-08-05
IQI FILLAUER EUROPE [FILLAUER COMPANIES, INC.]	TORONTO KIT	1992-08-05
IQI FILLAUER EUROPE [FILLAUER COMPANIES, INC.]	STEPLOCK	1992-08-05
IQI FILLAUER EUROPE [FILLAUER COMPANIES, INC.]	STANDING FRAME	1992-08-05
IQI FILLAUER EUROPE [FILLAUER COMPANIES, INC.]	SPRING WIRE DORSI FL	1992-08-05
IQI FILLAUER EUROPE [FILLAUER COMPANIES, INC.]	SPIRAL AFO KIT	1992-08-05
IQI FILLAUER EUROPE [FILLAUER COMPANIES, INC.]	SCOTTISH RITE KIT WITH SPREADER BAR	1992-08-05
IQI FILLAUER EUROPE [FILLAUER COMPANIES, INC.]	SCOTTISH RITE KIT W	1992-08-05
IQI FILLAUER EUROPE [FILLAUER COMPANIES, INC.]	RECIPROCATOR KIT	1992-08-05
IQI FILLAUER EUROPE [FILLAUER COMPANIES, INC.]	POSTERIOR LEAF SPRING ORTHOLEN	1992-08-05
IQI FILLAUER EUROPE [FILLAUER COMPANIES, INC.]	PELVIC BAND WITH HIP JOINT	1992-08-05
IQI FILLAUER EUROPE [FILLAUER COMPANIES, INC.]	PAVLIK HARNESS	1992-08-05
IQI FILLAUER EUROPE [FILLAUER COMPANIES, INC.]	INSERT	1992-08-05
IQI FILLAUER EUROPE [FILLAUER COMPANIES, INC.]	HEMI SPIRAL AFO KIT	1992-08-05
IQI FILLAUER EUROPE [FILLAUER COMPANIES, INC.]	HARVEY ARM ABDUCTION ORTHOSIS	1992-08-05
IQI FILLAUER EUROPE [FILLAUER COMPANIES, INC.]	FOOT ORTHOTICS	1992-08-05
IQI FILLAUER EUROPE [FILLAUER COMPANIES, INC.]	FILLAUER NIGHT SPLINT	1992-08-05
IQI FILLAUER EUROPE [FILLAUER COMPANIES, INC.]	ANKLE JOINT ASSEMBLY	1992-08-05
IQI FILLAUER EUROPE [FILLAUER COMPANIES, INC.]	ABDUCTION ORTHOSIS	1992-08-05
IQI FILLAUER EUROPE [FILLAUER COMPANIES, INC.]	A FRAME ORTHOSIS	1992-08-05
IOZ FILLAUER, LLC [FILLAUER COMPANIES, INC.]	VON ROSEN SPLINT	1992-08-05
IOZ FILLAUER, LLC [FILLAUER COMPANIES, INC.]	PAVLIK HARNESS	1992-08-05
IOZ FILLAUER, LLC [FILLAUER COMPANIES, INC.]	FILLAUER A FRAME	1992-08-05