Flexercycle

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

510(k) Number

K904823 ↗

FDA Product Code

ISD

Device Class

Class II

Regulation

21 CFR Part 890.5360

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• KT2000 Knee Ligament Arthrometer

  Class I

  FDA 510(k) K942059 Active Cleared 20 Sep 1994

• Tension-Isometer

  Class I

  FDA 510(k) K854254 Active Cleared 15 Nov 1985

• Drawer Test

  Class I

  FDA 510(k) K812713 Active Cleared 5 Nov 1981

• Torque Frame QTF1000

  Class II

  FDA 510(k) K904898 Active Cleared 28 Nov 1990

• Surg-Assist

  Class I

  FDA 510(k) K801572 Active Cleared 4 Aug 1980

• KT1000/S Knee Ligament Arthrometer

  Class I

  FDA 510(k) K943197 Active Cleared 2 Mar 1995

See all devices from Medmetric Corp. →

• What is the primary purpose of the Flexercycle?

  The Flexercycle is a physical medicine device designed to facilitate exercise and measurement functions. It is intended for use in clinical or therapeutic applications to support patient movement and assessment.

• What is the regulatory status of the Flexercycle?

  The Flexercycle is identified by FDA 510(k) number K904823. It is regulated under 21 CFR 890.5360 and was subject to traditional clearance procedures by the FDA.

• Who manufactures the Flexercycle and how is it classified?

  The device is manufactured by Medmetric Corp., which is based in San Diego, California. It is classified as a Class 2 device under the physical medicine specialty.