Product Code: ILP FDA class 1 21 CFR 890.3700

System, Communication, Non-Powered

Physical Medicine

A Non-Powered Communication System is a low-technology augmentative and alternative communication device used in Physical Medicine and occupational therapy to assist patients with speech or motor impairments in communicating, typically consisting of symbol boards, letter charts, or picture-based communication aids that require no electrical power. 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 ILP, regulated under 21 CFR 890.3700, 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

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Basic Information

Product Code: ILP
Device Class: FDA class 1
Regulation Number: 890.3700
Medical Specialty: Physical Medicine
Review Panel: PM
Submission Type: 4

Device Characteristics

✓

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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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
K844890	TELL ME TAGS - NONPOWERED COMMUNICATION SYS	Mar 08, 1985	Substantially Equivalent	Mina Manufacturers, Inc.
K840112	SPEECH TEACHER	Mar 22, 1984	Substantially Equivalent	Joseph A. Resnick
K831546	ADAPTIVE PENS & LAP DESK	Jun 08, 1983	Substantially Equivalent	Fred Sammons, Inc.
K823625	MOUTH STICK KIT	Dec 30, 1982	Substantially Equivalent	Fred Sammons, Inc.
K823624	HOLDER FOR MOUTH STICK	Dec 30, 1982	Substantially Equivalent	Fred Sammons, Inc.
K823612	ADJ. WOODEN BOARD FOR WRITING	Dec 30, 1982	Substantially Equivalent	Fred Sammons, Inc.
K823608	PICTURES & WORD IDENTIFICATION CVA PAT	Dec 30, 1982	Substantially Equivalent	Fred Sammons, Inc.
K823617	PLASTIC SLIP-ON POINTS W/RUBBER TIP FOR	Dec 22, 1982	Substantially Equivalent	Fred Sammons, Inc.
K823616	PLASTIC SLIP-ON PEN/PENCIL HOLDER	Dec 22, 1982	Substantially Equivalent	Fred Sammons, Inc.
K823615	TELEPHONE ADAPTOR-PERSONS CANT ANSWER	Dec 22, 1982	Substantially Equivalent	Fred Sammons, Inc.
K823614	FLEXIBLE HOLDER TO HOLD PHONE RECEIVER	Dec 22, 1982	Substantially Equivalent	Fred Sammons, Inc.
K823613	PLASTIC STOP TO HOLD TELEPHONE BUTTON	Dec 22, 1982	Substantially Equivalent	Fred Sammons, Inc.
K823610	BK-4015 ECONOMY COMMUNICATION SHEET	Dec 22, 1982	Substantially Equivalent	Fred Sammons, Inc.
K823609	KIT OF WORDS & LTRS TO RE-LEARN-BK4014	Dec 22, 1982	Substantially Equivalent	Fred Sammons, Inc.
K821644	VACUUM WAND AND UNI-READER	Jun 11, 1982	Substantially Equivalent	Fred Sammons, Inc.
K811483	STIM STAND	Jun 16, 1981	Substantially Equivalent	Fred Sammons, Inc.
K811487	BOOK HOLDER	Jun 12, 1981	Substantially Equivalent	Fred Sammons, Inc.
K810452	NON-POWERED COMMUNICATION SYSTEMS	Mar 04, 1981	Substantially Equivalent	Fred Sammons, Inc.
K781204	BOOK HOLDER	Jul 31, 1978	Substantially Equivalent	Fred Sammons, Inc.
K770032	PAGE TURNER	Jan 12, 1977	Substantially Equivalent	Possum, Inc.
K761117	KEYBOARD SHEILDS	Dec 02, 1976	Substantially Equivalent	Fred Sammons, Inc.