Sliding Arm Support

FDA 510(k) K885105 · Rolcontrol Products, Co., Inc.

Substantially Equivalent

510(k) numberK885105

Submission

Device name
Sliding Arm Support
Applicant
Rolcontrol Products, Co., Inc.
Camarillo, CA, US
Received
December 12, 1988
Decision date
December 27, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KNN – Components, Wheelchair
Device class
Class I (low risk)
Regulation
21 CFR 890.3920
Specialty
Physical Medicine

Other 510(k)s with product code KNN

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K211919KISS Dynamic Back Support, KISS Dynamic Solid Drop SeatKNN · Traditional Kinetic Innovative Seating System, LLC03/04/2022SE
K942311Dynasty U1-33 AgmKNN · Traditional Foley & Lardner11/07/1994SE
K942310Dynasty GC 12550 (Gell/Cell)KNN · Traditional Foley & Lardner11/07/1994SE
K942309Dynasty U1-31 (Gell/Cell)KNN · Traditional Foley & Lardner11/07/1994SE
K942308Dynasty GC 12400 (Gell/Cell)KNN · Traditional Foley & Lardner11/07/1994SE
K942312Alden Lineage Wheelchair CushionKNN · Traditional Lewis W. Ward05/26/1994SE
K942260Alden Wheelchair CushionKNN · Traditional Ward and Assoc.05/26/1994SE
K933051Zero Gravity Wheelchair Components, ModificationKNN · Traditional General Components Intl., Inc.10/12/1993SE
K925980PMKNN · Traditional Pathfinder Intl. Corp.03/24/1993SE
K923942Rhombo Medical Rhombo-FillKNN · Traditional International Medical Products, Inc.03/24/1993SE

More from International Medical Products, Inc.

510(k)DeviceDecision
K885106Removable Battery Power SystemKNN · Traditional 12/27/1988SE
K885104Laydown Arm Support MechanismKNN · Traditional 12/27/1988SE
K8851031600 Light Touch ControlITI · Traditional 12/27/1988SE
K883679Wheels-Off Quick Release Axle SystemKNN · Traditional 09/13/1988SE
K8836784007 Model Recliner ControllerITI · Traditional 09/13/1988SE
K883674Manual Swing ArmITI · Traditional 09/13/1988SE
K883673Power Mechanical ReclinerITI · Traditional 09/13/1988SE
K883672Paralyzed Veterans of America Power ReclinerITI · Traditional 09/13/1988SE
K883671805 Power Chair Conversion SystemITI · Traditional 09/13/1988SE

Questions and answers

When was Sliding Arm Support cleared by the FDA?

Sliding Arm Support (K885105) received a 510(k) decision of Substantially Equivalent on December 27, 1988, 15 days after the submission was received.

What is the product code of K885105?

The FDA product code is KNN – Components, Wheelchair, a Class I (low risk) device regulated under 21 CFR 890.3920.