Wheel Chair Accessories

FDA 510(k) K821642 · Fred Sammons, Inc.

Substantially Equivalent

510(k) numberK821642

Submission

Device name
Wheel Chair Accessories
Applicant
Fred Sammons, Inc.
Mchenry, IL, US
Received
June 3, 1982
Decision date
June 11, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KNO – Accessories, Wheelchair
Device class
Class I (low risk)
Regulation
21 CFR 890.3910
Specialty
Physical Medicine

Other 510(k)s with product code KNO

510(k)DeviceApplicantDecision
K870298Redman AccessoriesKNO · Traditional Redman, Inc.02/26/1987SE
K823646Friction FeederKNO · Traditional Fred Sammons, Inc.01/21/1983SE
K823645Velcro Straps to Hold Arm to WheelchairKNO · Traditional Fred Sammons, Inc.01/21/1983SE
K823816Wheelchair Patient RestraintsKNO · Traditional Danek Medical, Inc.01/14/1983SE
K823636Arm Through for Wheelchair BK-6459-01 &KNO · Traditional Fred Sammons, Inc.12/28/1982SE
K823635Cushions for Wheelchair ArmsKNO · Traditional Fred Sammons, Inc.12/28/1982SE
K823596Clamp on Holder for a Glass or CupKNO · Traditional Fred Sammons, Inc.12/22/1982SE
K823595Head Support for WheelchairKNO · Traditional Fred Sammons, Inc.12/22/1982SE
K820964Wheelchair PalKNO · Traditional Pryor Products04/16/1982SE
K813627BK-6453 Rimmed Acrylic Lap Tray KitKNO · Traditional Fred Sammons, Inc.01/19/1982SE

More from Fred Sammons, Inc.

510(k)DeviceDecision
K880644Ultra-Pan for Orthotic Plastics (7262)IRQ · Traditional 05/06/1988SE
K880647Adult Perceptual Motor Puzzles (5331-01)HOX · Traditional 04/01/1988SE
K831549Arm SlingsILI · Traditional 06/30/1983SE
K831548SplintsILH · Traditional 06/27/1983SE
K831550Finger Boniometer BK7506KQW · Traditional 06/24/1983SE
K831544Deluxe Traction Exercise Glove BK5035IOD · Traditional 06/24/1983SE
K831543Adjust. WEIGHTS-BK5171-05,10,20 BeokION · Traditional 06/24/1983SE
K831542Adjustable Polycentric Elbow HingeIQI · Traditional 06/24/1983SE
K831553Leg Drainage Bag Strap BK6011KNX · Traditional 06/16/1983SE
K831552Sorbothane Visco Inner Sole PadKNP · Traditional 06/08/1983SE

Questions and answers

When was Wheel Chair Accessories cleared by the FDA?

Wheel Chair Accessories (K821642) received a 510(k) decision of Substantially Equivalent on June 11, 1982, 8 days after the submission was received.

What is the product code of K821642?

The FDA product code is KNO – Accessories, Wheelchair, a Class I (low risk) device regulated under 21 CFR 890.3910.