Product Code: ILC FDA class 1 21 CFR 890.5050

Utensil, Eating

Physical Medicine

Eating Utensils are adapted implements used in Physical Medicine and occupational therapy to assist patients with limited hand function, tremors, or upper limb disabilities in self-feeding, supporting independence in activities of daily living. 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 ILC, regulated under 21 CFR 890.5050, 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

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: ILC
Device Class: FDA class 1
Regulation Number: 890.5050
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 32 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K833177	GLOSSECTOMY FEEDING SPOONS	Oct 31, 1983	Substantially Equivalent	Maddak, Inc.
K830854	COLLAPSABLE LAVATORY SEAT HEIGHTENER	Apr 05, 1983	Substantially Equivalent	Lic-Orthion
K830851	BATH TUB SEAT & BATH BOARD	Apr 05, 1983	Substantially Equivalent	Lic-Orthion
K823594	PLASTIC BUILT-UP HANDLE EATING UTENSILS	Dec 22, 1982	Substantially Equivalent	Fred Sammons, Inc.
K821643	EATING UTENSILS	Jun 11, 1982	Substantially Equivalent	Fred Sammons, Inc.
K813630	BK-1129 BOTTLE STRAW	Jan 19, 1982	Substantially Equivalent	Fred Sammons, Inc.
K812346	ALUMINUM SCOOP DISK	Sep 11, 1981	Substantially Equivalent	Fred Sammons, Inc.
K811488	FEEDING AID KIT	Jun 12, 1981	Substantially Equivalent	Fred Sammons, Inc.
K810455	EATING UTENSILS	Mar 04, 1981	Substantially Equivalent	Fred Sammons, Inc.
K801706	BK-1426-00-01 STONYBROOK/HI-WALL PLATE	Aug 07, 1980	Substantially Equivalent	Fred Sammons, Inc.
K801705	BK-1424 INNER LIP PLATE, CERAMIC	Aug 07, 1980	Substantially Equivalent	Fred Sammons, Inc.
K800019	BK-1544 BE OK SCOOP DISK	Jan 21, 1980	Substantially Equivalent	Fred Sammons, Inc.
K790170	BK-1472 SPATULA SPOON	Feb 13, 1979	Substantially Equivalent	Fred Sammons, Inc.
K781196	UTENSILS, WEIGHTED	Jul 31, 1978	Substantially Equivalent	Fred Sammons, Inc.
K781193	KNIFE, LARGE HANDLE	Jul 31, 1978	Substantially Equivalent	Fred Sammons, Inc.
K781192	KNIFE, ROCKER, SLOTTED HANDLE	Jul 31, 1978	Substantially Equivalent	Fred Sammons, Inc.
K781191	SPORKS, PLASTIC, DISP.	Jul 31, 1978	Substantially Equivalent	Fred Sammons, Inc.
K771274	QUADRIPLEGIC MEAT KNIFE	Jul 21, 1977	Substantially Equivalent	Fred Sammons, Inc.
K770169	BEESON AUTOMADDAK FEEDER	Jan 28, 1977	Substantially Equivalent	Techhnilab Instruments, Inc.
K761113	BUILT-UP HANDLE UTENSILS	Dec 02, 1976	Substantially Equivalent	Fred Sammons, Inc.
K761112	PLASTIC HAND CONE	Dec 02, 1976	Substantially Equivalent	Fred Sammons, Inc.
K761111	SQUARE FOOD GUARD	Dec 02, 1976	Substantially Equivalent	Fred Sammons, Inc.
K761107	FOOD GUARDS	Dec 02, 1976	Substantially Equivalent	Fred Sammons, Inc.
K761106	WEIGHTED FORK	Dec 02, 1976	Substantially Equivalent	Fred Sammons, Inc.
K761105	WEIGHTED SPORK	Dec 02, 1976	Substantially Equivalent	Fred Sammons, Inc.
K761104	ADULT SWIVEL FORK	Dec 02, 1976	Substantially Equivalent	Fred Sammons, Inc.
K760286	SPOON, SOFT FOOD FEEDER, BK-1473	Sep 08, 1976	Substantially Equivalent	Fred Sammons, Inc.
K760285	CONE, HAND, BK-1501	Sep 08, 1976	Substantially Equivalent	Fred Sammons, Inc.
K760284	GLASS, NOSEY CUTOUT, BK-1146	Sep 08, 1976	Substantially Equivalent	Fred Sammons, Inc.
K760283	GLASS, SIP N' STRAW WITH LID, 1143	Sep 08, 1976	Substantially Equivalent	Fred Sammons, Inc.
K760282	CUP HOLDER/CUP,BK-1140	Sep 08, 1976	Substantially Equivalent	Fred Sammons, Inc.
K760281	CUP HOLDER/CUP, WHEELCHAIR	Sep 08, 1976	Substantially Equivalent	Fred Sammons, Inc.