ISD — Exerciser, Measuring Class II
FDA product code ISD covers "Exerciser, Measuring", a Class II medical device regulated under 21 CFR 890.5360. Submissions are reviewed by the Physical Medicine panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |