Collins Pedalmate 2

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

510(k) Number

K781889 ↗

FDA Product Code

ISD

Device Class

Class II

Regulation

21 CFR Part 890.5360

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Rs-Residual Volume System

  Class II

  FDA 510(k) K831778 Active Cleared 31 Aug 1983

• Pulmonary Function Tester, Computerized

  Class II

  FDA 510(k) K780328 Active Cleared 14 Mar 1978

• Collins Ds

  Class II

  FDA 510(k) K831777 Active Cleared 31 Aug 1983

• The Spira Elektro 2

  Class I

  FDA 510(k) K871151 Active Cleared 15 May 1987

• Shell Kraton Thermo-Plastic Rubber Comp.

  Class I

  FDA 510(k) K803069 Active Cleared 22 Dec 1980

• Collin Body Plethysmograph Plus System

  Class II

  FDA 510(k) K852102 Active Cleared 31 Jul 1985

See all devices from Warren E. Collins, Inc. →

• What is the Collins Pedalmate 2 used for?

  The Collins Pedalmate 2 is an exerciser and measuring device used in physical medicine to measure work output during exercise, typically for cardiac stress testing or rehabilitation purposes.

• How is the Collins Pedalmate 2 supplied?

  The Collins Pedalmate 2 is supplied by Warren E. Collins, Inc. and is classified as a Class II medical device with FDA 510(k) clearance K781889.

• What is the regulatory status of the Collins Pedalmate 2?

  The Collins Pedalmate 2 has FDA 510(k) clearance K781889, granted on November 22, 1978. It is regulated under product code ISD and regulation number 890.5360.

• Is the Collins Pedalmate 2 a single-use or reusable device?

  The device data does not specify whether the Collins Pedalmate 2 is designed for single-use or multiple uses. This information would need to be obtained directly from the manufacturer or product documentation.