Product Code: IKE FDA class 1 21 CFR 890.1615

Transducer, Miniature Pressure

Physical Medicine

A Miniature Pressure Transducer is a small sensing device used in Physical Medicine to measure localized pressure within tissues, joints, or body cavities, providing data for diagnostic evaluation of musculoskeletal or neuromuscular conditions. 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 IKE, regulated under 21 CFR 890.1615, within the Physical Medicine medical specialty.

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510(k)s

FEI Numbers

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Basic Information

Product Code: IKE
Device Class: FDA class 1
Regulation Number: 890.1615
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 15 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K060125	SONIC PALPOMETER	Mar 16, 2006	Substantially Equivalent	Palpometer Systems, Inc.
K954670	PRESSORE MONITOR	Oct 30, 1995	Substantially Equivalent	Cleveland Medical Devices, Inc.
K915369	THE EQUALIZER	Mar 22, 1993	Substantially Equivalent	Advanced Rehabilitative Technology, Inc.
K915326	PORTABLE LIMB LOAD MONITOR (BMLLM-100)	Oct 20, 1992	Substantially Equivalent	Bar Med Pty , Ltd.
K920091	IOWA ORAL PERFORMANCE ISNTRUMENT	May 20, 1992	Substantially Equivalent	Breakthrough, Inc.
K915897	FPL	Apr 07, 1992	Substantially Equivalent	Wrm Computers
K914780	TALLEY SD.500 SKIN PRESSURE EVALUATOR	Dec 19, 1991	Substantially Equivalent	Talley Group, Ltd.
K902967	MICRO-EMED-SYSTEM	Sep 17, 1990	Substantially Equivalent	Novel Electronics, Inc.
K880912	DYNATRON 2000	Mar 15, 1988	Substantially Equivalent	Dynatronics Corp.
K875103	BIO-FEEDBACK LIMB MONITOR TYPE CODE BL-34-1	Jan 20, 1988	Substantially Equivalent	Shield Computers , Ltd.
K871690	EMED-F-SYSTEM	May 15, 1987	Substantially Equivalent	Novel GmbH
K864569	PODODIGITAL	Feb 04, 1987	Substantially Equivalent	Broadwest Corp.
K864499	PODOSCOPE	Feb 04, 1987	Substantially Equivalent	Broadwest Corp.
K844202	MOSS LIMB LOAD MONITOR LM101-1	Nov 27, 1984	Substantially Equivalent	Moss Rehabilation Hospital
K843634	ASC 4080 SYSTEM	Nov 08, 1984	Substantially Equivalent	Atlantis Scientific Corp.