Product Code: ILH FDA class 1 21 CFR 890.3475

Splint, Hand, And Components

Physical Medicine

A Hand Splint and Components is an orthotic device used in Physical Medicine and occupational therapy to immobilize, support, or position the hand and wrist, used in the treatment of injuries, post-surgical recovery, neurological conditions, and rheumatic diseases. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. The product code is ILH, regulated under 21 CFR 890.3475, within the Physical Medicine medical specialty. This device is GMP exempt, indicating it is not subject to full good manufacturing practice requirements.

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510(k)s

FEI Numbers

416

Registration Numbers

416

Unique Applicants

Years Active

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Basic Information

Product Code: ILH
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 36 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K832144	SPLINT WOOD	Aug 01, 1983	Substantially Equivalent	Vermont Wood Industries, Inc.
K831548	SPLINTS	Jun 27, 1983	Substantially Equivalent	Fred Sammons, Inc.
K823647	FINGER EXTENSION SPLINT	Jan 21, 1983	Substantially Equivalent	Fred Sammons, Inc.
K823644	FINGER FLEXION SPLINT	Jan 21, 1983	Substantially Equivalent	Fred Sammons, Inc.
K823666	UNIVERSAL WRIST SPLINT & FOREARM SPLINT	Dec 30, 1982	Substantially Equivalent	Warm & Form, Orthopedic Materials
K823601	WRIST SUPPORT	Dec 22, 1982	Substantially Equivalent	Fred Sammons, Inc.
K823393	STAX FINGER SPLINTS	Dec 03, 1982	Substantially Equivalent	Orthopedic Systems, Inc.
K823165	WRIST SPLING & FOREARM SPLINT	Nov 16, 1982	Substantially Equivalent	Warm & Form, Orthopedic Materials
K822651	TOTAL FINGER FLEXION SPLINT	Sep 17, 1982	Substantially Equivalent	Alimed, Inc.
K821637	WIRE-FOAM MP FLEXION SPRING	Jun 11, 1982	Substantially Equivalent	Fred Sammons, Inc.
K821635	SOFT ULNAR DEVIATION SPLINTS	Jun 11, 1982	Substantially Equivalent	Fred Sammons, Inc.
K820826	STAX FINGER SPLINT	Apr 08, 1982	Substantially Equivalent	Conco Medical Co.
K820382	FROG SPLINT	Mar 01, 1982	Substantially Equivalent	Conco Medical Co.
K820381	FINGER PROTECTOR	Mar 01, 1982	Substantially Equivalent	Conco Medical Co.
K820380	CURVED FINGER SPLINT	Mar 01, 1982	Substantially Equivalent	Conco Medical Co.
K820383	FINGER COT	Feb 24, 1982	Substantially Equivalent	Conco Medical Co.
K812655	VELCRO SPLINT STRAP FASTENERS	Sep 25, 1981	Substantially Equivalent	Maddak, Inc.
K812654	VELCRO FINGER/TOE SPLINT	Sep 25, 1981	Substantially Equivalent	Maddak, Inc.
K812349	HAND SPLINTS & COMPONENTS	Sep 11, 1981	Substantially Equivalent	Fred Sammons, Inc.
K810442	HAND SPLINTS AND COMPONENTS	Mar 04, 1981	Substantially Equivalent	Fred Sammons, Inc.
K810109	METAL SPLINTS	Jan 26, 1981	Substantially Equivalent	Secol Co.
K801707	BK-1499 KAY-KPLINT HAND CONE/BK-1500	Aug 20, 1980	Substantially Equivalent	Fred Sammons, Inc.
K801714	TRANS DISTAL JOINT FINGER EXTEN. SPLINT	Aug 07, 1980	Substantially Equivalent	Fred Sammons, Inc.
K800143	DYNAMIC EXTENSOR SPLINT	Feb 19, 1980	Substantially Equivalent	Biomet, Inc.
K790182	2 VELCRO SPLINT STRAP	Feb 15, 1979	Substantially Equivalent	Fred Sammons, Inc.
K790181	SOFT SPLINT STRAPS	Feb 13, 1979	Substantially Equivalent	Fred Sammons, Inc.
K790180	PLATFORM SPLINTS	Feb 13, 1979	Substantially Equivalent	Fred Sammons, Inc.
K772416	PRE-FORMED SPLINT BLANKS	Jan 05, 1978	Substantially Equivalent	Fred Sammons, Inc.
K772411	PLATFORM SPLINTS	Jan 05, 1978	Substantially Equivalent	Fred Sammons, Inc.
K772410	RESTING PAN SPLINTS	Jan 05, 1978	Substantially Equivalent	Fred Sammons, Inc.
K770786	SPLINTS, FINGER/TOE	May 18, 1977	Substantially Equivalent	Depuy, Inc.
K761134	PLASTIC FINGER CUFFS	Dec 02, 1976	Substantially Equivalent	Fred Sammons, Inc.
K761131	SAFETY PIN SPLINT	Dec 02, 1976	Substantially Equivalent	Fred Sammons, Inc.
K760300	PADDING, TEMPER STICK FOAM, BK-7175	Sep 08, 1976	Substantially Equivalent	Fred Sammons, Inc.
K760299	STRIP, CLOSED CELL FOAM, BK-7171	Sep 08, 1976	Substantially Equivalent	Fred Sammons, Inc.
K760298	SUPPORT, WRIST, FIRM WIRE-FOAM	Sep 08, 1976	Substantially Equivalent	Fred Sammons, Inc.