Tool · 510(k)

510(k) Predicate Finder

Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

Product Code: INO FDA class 2

Chair, Positioning, Electric

Physical Medicine

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An Electric Positioning Chair is a motorized patient chair used in Physical Medicine that uses electrical actuation to adjust the seat position, backrest angle, and leg support, enabling precise repositioning of patients with limited mobility for therapeutic purposes or pressure management. It is classified as FDA Class 2, representing moderate risk, meaning it requires a 510(k) premarket notification demonstrating substantial equivalence to a predicate device before marketing. The product code is INO, regulated under 21 CFR 890.3110, within the Physical Medicine medical specialty.

510(k) Clearances

50+ matches
K Number
Device Name
DALTON LIFT CHAIR
EASYSTAND BANTAM MEDIUM
FRESENIUS MEDICAL TREATMENT CHAIR T688 SERIES
COMPACT WHEELCHAIR PLATFORM
LIFT CHAIR, MODEL T3
MEDICAL TREATMENT CHAIR, T400, T500,T600
BANTAM
STANDARD WHEELCHAIR PLATFORM
PIVOT ASSIST
WINCO MODEL POWER SERIES LIFT CHAIR
CONVERTIBLE I-SERIES POSITIONING AND TRANSFER CHAIR
LIFT CHAIR, MODEL C5
EASYSTAND EVOLV
MERITS MODEL E SERIES LIFT CHAIRS
AEROLET TOILET LIFT, MODEL AER-01
EASY LIFE
MULTI FUCTIONAL REHABILITATION CHAIR
UNITED #1018-FREEDOM SERIES, UNITED #2018-COMFORT SERIES, UNITED #3018-ELEGANCE SERIES, UNITED #5018-MASTER SERIES
MEDLINE ELECTRONIC POSITIONING CHAIR
INVACARE LIFT CHAIR
TWO RIVERS POWER LIFT/RECLINE CHAIR
PREVENT I
ELECTRIC SEAT LIFT CHAIR
TMR48
577ES (ERGOSENSE)
ACTION-LIFT CHAIR
TMR-670
UNIVERSAL WHEELCHAIR LIFT
TREATMENT TABLE, MODEL #825-100
PORTABLE LIFT SEAT
BIOPHYSIOMETER POSITIONING CHAIR
SERIES 9000 LIFT-RECLINE CHAIR
MODIFIED CHAIRS (DENTAL, MEDICAL, AND PODIATRY)
KARE CHAIR I
AMOS BOY LIFT CHAIR
ASSIST-A-LIFT
POWER TOILET ELEVATOR
MECHANICAL ADJUSTABLE CHAIR (AC POWERED)
GOLDEN POWER LIFT CHAIR
BUSHLINE CARE CHAIR
HEALTH PRODUCTS, INC. ORTHODERM THERAPY CHAIR
COMFORT+LIFT CHAIR
FRANKLIN CHAIRS/MOVES, #4000 SERIES & #4100 SERIES
MODIFIED PENOX LIFT CHAIR
COMFORT + LIFT
GENTLE LIFT-RECLINER CHAIR
PENOX LIFT CHAIR
HILO TABLES, TYPE CH-4, CH-8, FW-6, FW-5, FW-2, AL
CONTOUR CHAIR LOUNGE W/OPTIIONAL HEAT & MASSAGE
NOVA LIFT CHAIR

What is a Predicate Device?

A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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