Product Code: ILI FDA class 1 21 CFR 890.3640

Sling, Arm

Physical Medicine

An Arm Sling is an orthotic support device used in Physical Medicine to immobilize and protect the upper limb following fractures, dislocations, sprains, or surgery, holding the arm in a flexed position against the body during the healing process. 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 ILI, regulated under 21 CFR 890.3640, 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

326

Registration Numbers

326

Unique Applicants

Years Active

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Basic Information

Product Code: ILI
Device Class: FDA class 1
Regulation Number: 890.3640
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 21 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K912661	MATRX, PYRAMID TRIANGLE BANDAGE	Aug 21, 1991	Substantially Equivalent	Matrix Medica, Inc.
K831549	ARM SLINGS	Jun 30, 1983	Substantially Equivalent	Fred Sammons, Inc.
K831706	SATO FAMILY FIRST AID KIT	Jun 24, 1983	Substantially Equivalent	Food and Drug Service, Inc.
K823810	A.C. SPLINT	Jan 14, 1983	Substantially Equivalent	Danek Medical, Inc.
K823808	VARIOUS ARM SLING	Jan 14, 1983	Substantially Equivalent	Danek Medical, Inc.
K823664	UNIVERSAL SLING, SLING & SWATHE	Dec 30, 1982	Substantially Equivalent	Warm & Form, Orthopedic Materials
K823162	UNIVERSAL SLING, SLING & SWATHE	Nov 10, 1982	Substantially Equivalent	Warm & Form, Orthopedic Materials
K820590	ORTHOPEDIC SOFT GOODS	Mar 26, 1982	Substantially Equivalent	Abco Dealers, Inc.
K812480	LIMB HOLDER ARM SLING	Sep 14, 1981	Substantially Equivalent	Maddak, Inc.
K812478	MADDACOMFORT SLING	Sep 14, 1981	Substantially Equivalent	Maddak, Inc.
K812477	ARM SLING, POUCH TYPE	Sep 14, 1981	Substantially Equivalent	Maddak, Inc.
K812345	ARM SLINGS	Sep 11, 1981	Substantially Equivalent	Fred Sammons, Inc.
K803212	BAUER & BLACK ARM SLING W/DETACH. POUCH	Jan 08, 1981	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K803139	CONPHAR ARM SLINGS	Jan 08, 1981	Substantially Equivalent	Conphar, Inc.
K802006	TRIANGULAR BANDAGE CAT.#191	Sep 16, 1980	Substantially Equivalent	Pollak (Intl.), Ltd.
K801713	BK-6157-02 C.V.A SLING, MEDIUM&LARGE	Aug 07, 1980	Substantially Equivalent	Fred Sammons, Inc.
K801626	ARM SLING	Jul 28, 1980	Substantially Equivalent	The Owenby Co.
K801531	ARM SLING	Jul 21, 1980	Substantially Equivalent	The Owenby Co.
K771031	STROKE SLING	Jun 27, 1977	Substantially Equivalent	Stat Medical Corp.
K760574	ECONOMY IMMOBILIZATION AND VELPEAN SLING	Oct 06, 1976	Substantially Equivalent	Richard'S Medical Equip., Inc.
K760250	BANDAGE, TRIANGULAR NO. 8068	Jul 26, 1976	Substantially Equivalent	Johnson & Johnson Professionals, Inc.