ISD — Exerciser, Measuring Class II
FDA Device Classification
Classification Details
- Product Code
- ISD
- Device Class
- Class II
- Regulation Number
- 890.5360
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K202979 | lode | MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Do | December 21, 2020 |
| K183296 | penumbra | REAL Immersive System | March 18, 2019 |
| K143512 | sleep modus | ActiSpec Activity Monitor | August 26, 2015 |
| K112121 | ergoline | ERGOSELECT/GE | October 31, 2012 |
| K080545 | actigraph | ACTITRAINER | July 24, 2008 |
| K053078 | ergoline | ERGOSELECT 100 K/P, ERGOSELECT 200 K/P | April 27, 2006 |
| K990866 | quinton | QUINTON MEDTRACK CR PLUS TREADMILL | April 29, 1999 |
| K990813 | electromed | REHCOR | April 12, 1999 |
| K962855 | penny and giles biometrics | ULE-2, MULE-2, HAND ACCESSORY KIT | December 11, 1996 |
| K952163 | kinetic resources | DAVID BACK CLINIC SYSTEM | August 12, 1996 |
| K941033 | longo industries | PHYSIO HAB | February 27, 1995 |
| K940065 | southwest ergonomics | SES100 | December 6, 1994 |
| K934238 | penny and giles biometrics | MULE | October 26, 1994 |
| K930735 | lordex | LORDEX LUMBAR EXTENSION MACHINE | September 29, 1994 |
| K933611 | baltimore therapeutic equipment | THE BTE WS30 | June 20, 1994 |
| K926279 | henley intl | UPPER BODY EXERCISER | May 5, 1994 |
| K926278 | henley intl | STAIR CLIMBER | May 5, 1994 |
| K926287 | henley intl | EXERCISE BICYCLE | March 22, 1994 |
| K926314 | henley intl | HYDRA FITNESS MODEL 311 TOTAL POWER | March 18, 1994 |
| K930253 | ergometrx | CARDIO2 CTCKE | October 18, 1993 |