Collins Pedalmate 2
FDA 510(k) K781889 · Warren E. Collins, Inc.
510(k) numberK781889
Submission
- Device name
- Collins Pedalmate 2
- Applicant
- Warren E. Collins, Inc.
Mchenry, IL, US - Received
- November 7, 1978
- Decision date
- November 22, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ISD – Exerciser, Measuring
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5360
- Specialty
- Physical Medicine
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|---|---|---|---|
| K202979 | MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal…ISD · Abbreviated | Lode B.V. | 12/21/2020SE |
| K183296 | REAL Immersive SystemISD · Traditional | Penumbra, Inc. | 03/18/2019SE |
| K143512 | ActiSpec Activity MonitorISD · Traditional | Sleep Modus, Inc. | 08/26/2015SE |
| K112121 | Ergoselect/GeISD · Traditional | Ergoline GmbH | 10/31/2012SE |
| K080545 | ActitrainerISD · Traditional | Actigraph, LLC | 07/24/2008SE |
| K053078 | Ergoselect 100 K/P, Ergoselect 200 K/PISD · Traditional | Ergoline GmbH | 04/27/2006SE |
| K990866 | Quinton Medtrack CR Plus TreadmillISD · Traditional | Quinton, Inc. | 04/29/1999SE |
| K990813 | RehcorISD · Traditional | Electromed Corp. | 04/12/1999SE |
| K962855 | ULE-2, MULE-2, Hand Accessory KitISD · Traditional | Penny and Giles Biometrics , Ltd. | 12/11/1996SE |
| K952163 | David Back Clinic SystemISD · Traditional | Kinetic Resources, Inc. | 08/12/1996SE |
More from Kinetic Resources, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K925459 | Gs-Modular (Gold Standard - Modular)BZG · Traditional | 02/04/1994SE |
| K912946 | Collins Digital Pulmonary ManometerBXR · Traditional | 01/15/1992SE |
| K871151 | The Spira Elektro 2CCQ · Traditional | 05/15/1987SE |
| K861227 | Collins Pneumotach PFT SystemBZG · Traditional | 06/05/1986SE |
| K852102 | Collin Body Plethysmograph Plus SystemCCM · Traditional | 07/31/1985SE |
| K831780 | Metabolic Exercise Testing SystemBZL · Traditional | 09/12/1983SE |
| K831778 | Rs-Residual Volume SystemBZC · Traditional | 08/31/1983SE |
| K831777 | Collins DSBZC · Traditional | 08/31/1983SE |
| K831779 | Collins Eagle IIBZC · Traditional | 08/26/1983SE |
| K803069 | Shell Kraton Thermo-Plastic Rubber Comp.BYP · Traditional | 12/22/1980SE |
Questions and answers
When was Collins Pedalmate 2 cleared by the FDA?
Collins Pedalmate 2 (K781889) received a 510(k) decision of Substantially Equivalent on November 22, 1978, 15 days after the submission was received.
What is the product code of K781889?
The FDA product code is ISD – Exerciser, Measuring, a Class II (moderate risk) device regulated under 21 CFR 890.5360.