Product Code: KNO FDA class 1 21 CFR 890.3910

Accessories, Wheelchair

Physical Medicine

Wheelchair Accessories are supplemental attachments, cushions, trays, bags, and other add-on items designed to enhance the comfort, function, safety, or adaptability of wheelchairs for individuals with mobility impairments. It is classified as FDA Class 1, indicating low risk subject to general controls with no premarket submission required. The product code is KNO and the applicable regulation is 21 CFR 890.3910 in the Physical Medicine specialty. This device is GMP exempt.

510(k)s
35
FEI Numbers
217
Registration Numbers
217
Unique Applicants
7
Years Active
10

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Basic Information

Product Code
KNO
Device Class
FDA class 1
Regulation Number
890.3910
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

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Related 510(k) Clearances

This FDA classification is associated with 35 510(k) clearances via K numbers.

K Number Device Name
K870298 REDMAN ACCESSORIES
K823646 FRICTION FEEDER
K823645 VELCRO STRAPS TO HOLD ARM TO WHEELCHAIR
K823816 WHEELCHAIR PATIENT RESTRAINTS
K823636 ARM THROUGH FOR WHEELCHAIR BK-6459-01 &
K823635 CUSHIONS FOR WHEELCHAIR ARMS
K823596 CLAMP ON HOLDER FOR A GLASS OR CUP
K823595 HEAD SUPPORT FOR WHEELCHAIR
K821642 WHEEL CHAIR ACCESSORIES
K820964 WHEELCHAIR PAL
K813627 BK-6453 RIMMED ACRYLIC LAP TRAY KIT
K812350 WHEELCHAIR ACCESSORIES
K811482 INCONTINENT PAD
K811486 WHEELCHAIR RAMPS
K811491 WHEELCHAIR ACCESSORIES
K810448 WHEELCHAIR ACCESSORIES
K810439 BODY STRAP
K801709 BK-5058-01 QUAD-QUIP WHEELCHAIR CUFF
K801489 EZ ON SAFETY PONCHO
K801214 HAMILTON TUCKAWAY DESK
K800208 SKIL-CARE LEG PADS
K790177 ASHTRAY FOR WHEELCHAIR
K790176 ADJUSTABLE HEIGHT DESK ARM LAP TRAY KIT
K781203 TRAY, LAP, MOLDED
K781202 VEST, SUPPORT, TRUNK
K781195 BAG, WALDER
K781194 BAG, WHEELCHAIR
K780195 WHEELCHAIR MUFF
K780194 TOE LOOPS
K780193 HEEL LOOPS
K780191 STRAP, LEGREST
K760296 ADJUSTER, WHEELCHAIR WIDTH, BK-6470
K760295 CARPET COVERS FOR FOOTRESTS, BK-6467
K760292 DESK, BEANBAG SHUFFLE, BK-6059
K760290 CANE OR CRUTCH PARKER (3/4, 7/8, L)

FEI Numbers

This FDA classification entry is associated with 217 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 217 registration numbers. Click on an entry to view related FDA registrations.