Armboard

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K833559 ↗

FDA Product Code

KPR

Device Class

Class II

Regulation

21 CFR Part 892.1680

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Patient Restraint System

  Class I

  FDA 510(k) K771659 Active Cleared 30 Sep 1977

• The Mtd Vara Set Casette Holder

  Class II

  FDA 510(k) K791374 Active Cleared 7 Sep 1979

• Arthrostress

  Class I

  FDA 510(k) K772321 Active Cleared 3 Jan 1978

• Medical Image Management Devices for Vision Tools

  Class II

  FDA 510(k) K063439 Active Cleared 22 Jan 2007

• What is the ARMBOARD device used for?

  The ARMBOARD is a stationary X-ray system used in radiology to support patient positioning during imaging procedures, as indicated by its classification as a System, X-Ray, Stationary device and its product code KPR under the Radiology medical specialty.

• How was the ARMBOARD cleared for market distribution?

  The ARMBOARD received FDA 510(k) clearance through a traditional submission process under K-number K833559 on January 3, 1984, after being determined substantially equivalent to a predicate device, as documented in its authorization and decision records.

• Who manufactures the ARMBOARD and where is it produced?

  The ARMBOARD is manufactured by Mtd, Inc., located at 803 N. Front St. Suite 3, McHenry, IL 60050, United States, as specified in the manufacturer and address fields of the device data.

• What regulatory classification does the ARMBOARD hold?

  The ARMBOARD is classified as a Class II medical device, as explicitly stated in the description and confirmed by the device_class=2 field in the openfda section of the data.

• What product code identifies the ARMBOARD in FDA databases?

  The ARMBOARD is identified by the product code KPR, which is listed in the product_code field and used to categorize the device within the FDA’s product code system for radiology equipment.