MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra
FDA 510(k) K202979 · Lode B.V.
510(k) numberK202979
Submission
- Device name
- MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra
- Applicant
- Lode B.V.
Groningen, NL - Received
- September 30, 2020
- Decision date
- December 21, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- ISD – Exerciser, Measuring
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5360
- Specialty
- Physical Medicine
Other 510(k)s with product code ISD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K941033 | Physio HabISD · Traditional | Longo Industries | 02/27/1995SE |
Questions and answers
When was MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra cleared by the FDA?
MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra (K202979) received a 510(k) decision of Substantially Equivalent on December 21, 2020, 82 days after the submission was received.
What is the product code of K202979?
The FDA product code is ISD – Exerciser, Measuring, a Class II (moderate risk) device regulated under 21 CFR 890.5360.