Firm-A-Tron

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

510(k) Number

K810634 ↗

FDA Product Code

IPF

FDA applicant

Biotron , Ltd.

Device Class

Class II

Regulation

21 CFR Part 890.5850

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Armtrol and Fermtrol

  Class I

  FDA 510(k) K780802 Active Cleared 13 Jun 1978

• The Universal Cement Plug(Tm)

  Class II

  FDA 510(k) K910135 Active Cleared 5 Mar 1991

• Firm-A-Tron Mark X

  Class II

  FDA 510(k) K843583 Active Cleared 29 Nov 1984

• Till-U-Test, Dip Slide

  Class I

  FDA 510(k) K780803 Active Cleared 6 Jun 1978

• What is the intended use of the Firm-A-Tron?

  The Firm-A-Tron is a medical device designed for applications within the field of physical medicine. It is categorized under product code IPF, which relates to devices used in therapeutic or rehabilitative physical medicine settings.

• What is the regulatory status of this device?

  The Firm-A-Tron received FDA 510(k) clearance on June 12, 1981, under submission number K810634. The device was determined to be substantially equivalent to existing devices, allowing it to be marketed under the Traditional 510(k) pathway.

• Who is the manufacturer of the Firm-A-Tron?

  The Firm-A-Tron is manufactured by Biotron, Ltd., located in McHenry, Illinois. The company submitted the device for regulatory review in March 1981, leading to its clearance later that year.