Product Code: IQI FDA class 1 21 CFR 890.3475

Orthosis, Limb Brace

Physical Medicine

A limb brace orthosis is an external support device applied to a limb to stabilize joints, correct alignment, or limit motion following injury, surgery, or in the management of neuromuscular conditions. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IQI, regulated under 21 CFR 890.3475, within the Physical Medicine medical specialty. This device is GMP exempt.

View on FDA

510(k)s

FEI Numbers

503

Registration Numbers

503

Unique Applicants

Years Active

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Basic Information

Product Code: IQI
Device Class: FDA class 1
Regulation Number: 890.3475
Medical Specialty: Physical Medicine
Review Panel: PM
Submission Type: 4

Device Characteristics

✓

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 52 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K143458	Neurosplint	Aug 13, 2015	Substantially Equivalent	Neurospectrum, LLC
K052771	SENSOR WALK	May 03, 2006	Substantially Equivalent	Otto Bock Healthcare LP
K031576	SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1	Jul 31, 2003	Substantially Equivalent	Surgitech, Inc.
K926391	ACCUFLEX DYNAMIC ELBOW ORTHOSIS	Jul 22, 1993	Substantially Equivalent	Regulatory & Marketing Services, Inc.
K910974	MCCONNELL SHOULDER BRACE	Mar 21, 1991	Substantially Equivalent	Mcconnell Orthopedic
K874502	GAIT-AID ORTHOPEDIC INSOLE	Nov 30, 1987	Substantially Equivalent	Gait-Aid, Inc.
K831542	ADJUSTABLE POLYCENTRIC ELBOW HINGE	Jun 24, 1983	Substantially Equivalent	Fred Sammons, Inc.
K831615	DROP FOOT BRACE	Jun 15, 1983	Substantially Equivalent	Edward Dilauro, Jr.
K823812	VARIOUS SUPPORTS AND SPLINTS	Jan 14, 1983	Substantially Equivalent	Danek Medical, Inc.
K823113	BRACE-UP ALL PURPOSE WRIST BAND	Nov 16, 1982	Substantially Equivalent	Arco Matic, Inc.
K823160	ROTATION BOOT	Nov 10, 1982	Substantially Equivalent	Warm & Form, Orthopedic Materials
K823114	BRACE-UP STOCKING KNEE BRACE	Nov 05, 1982	Substantially Equivalent	Arco Matic, Inc.
K822767	UNIVERSAL DYNASPLINT	Oct 06, 1982	Substantially Equivalent	Dynasplint Systems, Inc.
K822022	SPORT SUPPORTS	Jul 26, 1982	Substantially Equivalent	Ginny, Inc.
K821704	FRACTURE BRACING	Jun 24, 1982	Substantially Equivalent	Hosmer Dorrance Corp.
K821641	OBTHOSES	Jun 11, 1982	Substantially Equivalent	Fred Sammons, Inc.
K821640	ORTHOTIC FABRICATION ACCESSORIES	Jun 11, 1982	Substantially Equivalent	Fred Sammons, Inc.
K821582	WARM'N FORM SPORTS SUPPORTS	Jun 10, 1982	Substantially Equivalent	Jerome Medical
K820469	WARM & FORM KNEE SUPPORTS	Mar 08, 1982	Substantially Equivalent	Thermo-Mold Medical Products, Inc.
K811704	MULTITUBULAR AIR SPLINT KIT	Jul 01, 1981	Substantially Equivalent	Roger Cestac & Assoc.
K811690	ANKLE-FOOT CAST/SPLINT	Jun 25, 1981	Substantially Equivalent	Surgical Appliance Industries, Inc.
K811490	FOREARM & KNEE STRAPS	Jun 12, 1981	Substantially Equivalent	Fred Sammons, Inc.
K811456	ORTHO-FRAC KIT	Jun 12, 1981	Substantially Equivalent	Orthomedics
K811343	HUMERAL FRACTURE CAST BRACE	May 28, 1981	Substantially Equivalent	Deseret Medical, Inc.
K811035	PRO COMFORT TENNIS ELBOW SUPPORT/WRIST	Apr 29, 1981	Substantially Equivalent	Scholl, Inc.
K810443	LIMB ORTHOSIS	Mar 04, 1981	Substantially Equivalent	Fred Sammons, Inc.
K810288	AIRCAST TENNIS ARM BAND	Feb 12, 1981	Substantially Equivalent	Aircast, Inc.
K802910	PLASTIC FRACTURE CAST BRACE KNEE JOINT	Dec 22, 1980	Substantially Equivalent	Orthomedics
K802909	HUMERAL FRACTURE BRACE	Dec 17, 1980	Substantially Equivalent	Orthomedics
K802908	ULNAR FRACTURE BRACE	Dec 17, 1980	Substantially Equivalent	Orthomedics
K802871	TIBIAL FRACTURE BRACE	Dec 11, 1980	Substantially Equivalent	Orthomedics
K802104	C-SPLINT	Sep 16, 1980	Substantially Equivalent	Cutter Laboratories, Inc.
K801788	HUMEROUS FRACTURE BRACE, ULNA FRACTURE	Aug 07, 1980	Substantially Equivalent	Hosmer Dorrance Corp.
K801708	BK-1520-01 ECONOMY WRIST SUPPORT, CHILD	Aug 07, 1980	Substantially Equivalent	Fred Sammons, Inc.
K801701	BAUER & BLACK RIGID WRIST BRACE	Aug 07, 1980	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K800715	OHC DYNAMIC CLUB FOOT BRACE	May 02, 1980	Substantially Equivalent	Ipos Luneburg
K791565	PARAPODIUM	Aug 28, 1979	Substantially Equivalent	Physico-Medical Systems Corp.
K791267	SECUTEX ANKLE BAND	Jul 24, 1979	Substantially Equivalent	Conphar, Inc.
K791266	SECUTEX KNEE BAND	Jul 24, 1979	Substantially Equivalent	Conphar, Inc.
K791249	SECUTEX WRIST BRACE	Jul 24, 1979	Substantially Equivalent	Conphar, Inc.
K791248	SECUTE ELBOW BAND	Jul 24, 1979	Substantially Equivalent	Conphar, Inc.
K791057	CAST BRACE COMPONENTS	Jun 20, 1979	Substantially Equivalent	3M Company
K781206	FOOT POSITIONER	Jul 31, 1978	Substantially Equivalent	Fred Sammons, Inc.
K780979	AIRSTIRRUP PNEUMATIC ANKLE BRACE	Jun 30, 1978	Substantially Equivalent	Aircast, Inc.
K780225	ORTHOSISES DEVICES	Feb 24, 1978	Substantially Equivalent	Biomet, Inc.
K780053	BRACE, TENNIS ELBOW	Jan 17, 1978	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K771676	FOOT DROP BOOT	Sep 20, 1977	Substantially Equivalent	Medical Restraints, Inc.
K770612	SPLINT, BOHLER	Apr 08, 1977	Substantially Equivalent	Will Ross Co.
K770167	KNEE SEPARATOR	Jan 28, 1977	Substantially Equivalent	Bel-Art Products
K761312	ORTHOTIC BRACING	Jan 10, 1977	Substantially Equivalent	Hosmer Dorrance Corp.
K760950	DEVON KNEE STRAP	Nov 11, 1976	Substantially Equivalent	Devon Industries, Inc.
K760002	KNEE AID	Jul 26, 1976	Substantially Equivalent	Zimmer, Inc.