Rehcor
FDA 510(k) K990813 · Electromed Corp.
510(k) numberK990813
Submission
- Device name
- Rehcor
- Applicant
- Electromed Corp.
Deerfield, IL, US - Received
- March 11, 1999
- Decision date
- April 12, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| 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 |
| 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 |
| K941033 | Physio HabISD · Traditional | Longo Industries | 02/27/1995SE |
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| K040367 | Medpulse Respiratory Vest System, Model 2000EZBYI · Special | 04/07/2004SE |
| K982889 | Medpulse Respiratory Vest System, Model 1000BYI · Traditional | 06/01/1999SE |
Questions and answers
When was Rehcor cleared by the FDA?
Rehcor (K990813) received a 510(k) decision of Substantially Equivalent on April 12, 1999, 32 days after the submission was received.
What is the product code of K990813?
The FDA product code is ISD – Exerciser, Measuring, a Class II (moderate risk) device regulated under 21 CFR 890.5360.