ISD · Exerciser, Measuring
Physical Medicine · 21 CFR 890.5360 · Class 2
Overview
| Product Code | ISD |
|---|---|
| Device Name | Exerciser, Measuring |
| Regulation | 21 CFR 890.5360 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
Identification
Measuring exercise equipment consist of manual devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. These devices also include instrumentation, such as the pulse rate monitor, that provide information used for physical evaluation and physical planning purposes., Examples include a therapeutic exercise bicycle with measuring instrumentation, a manually propelled treadmill with measuring instrumentation, and a rowing machine with measuring instrumentation.
Classification Rationale
Class II (special controls). The device, when it is a measuring exerciser or an interactive rehabilitation exercise device for prescription use only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is a measuring exerciser or an interactive rehabilitation exercise device for prescription use only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
Recent Cleared Devices (20 of 61)
Showing 20 most recent of 61 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K202979 | MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra | Lode B.V. | Dec 21, 2020 | SESE |
| K183296 | REAL Immersive System | Penumbra, Inc. | Mar 18, 2019 | SESE |
| K143512 | ActiSpec Activity Monitor | Sleep Modus, Inc. | Aug 26, 2015 | SESE |
| K112121 | ERGOSELECT/GE | Ergoline GmbH | Oct 31, 2012 | SESE |
| K080545 | ACTITRAINER | Actigraph, LLC | Jul 24, 2008 | SESE |
| K053078 | ERGOSELECT 100 K/P, ERGOSELECT 200 K/P | Ergoline GmbH | Apr 27, 2006 | SESE |
| K990866 | QUINTON MEDTRACK CR PLUS TREADMILL | Quinton, Inc. | Apr 29, 1999 | SESE |
| K990813 | REHCOR | Electromed Corp. | Apr 12, 1999 | SESE |
| K962855 | ULE-2, MULE-2, HAND ACCESSORY KIT | Penny and Giles Biometrics , Ltd. | Dec 11, 1996 | SESE |
| K952163 | DAVID BACK CLINIC SYSTEM | Kinetic Resources, Inc. | Aug 12, 1996 | SESE |
| K941033 | PHYSIO HAB | Longo Industries | Feb 27, 1995 | SESE |
| K940065 | SES100 | Southwest Ergonomics | Dec 6, 1994 | SESE |
| K934238 | MULE | Penny and Giles Biometrics , Ltd. | Oct 26, 1994 | SESE |
| K930735 | LORDEX LUMBAR EXTENSION MACHINE | Lordex, Inc. | Sep 29, 1994 | SESE |
| K933611 | THE BTE WS30 | Baltimore Therapeutic Equipment Co. | Jun 20, 1994 | SESE |
| K926279 | UPPER BODY EXERCISER | Henley Intl. | May 5, 1994 | SESE |
| K926278 | STAIR CLIMBER | Henley Intl. | May 5, 1994 | SESE |
| K926287 | EXERCISE BICYCLE | Henley Intl. | Mar 22, 1994 | SESE |
| K926314 | HYDRA FITNESS MODEL 311 TOTAL POWER | Henley Intl. | Mar 18, 1994 | SESE |
| K930253 | CARDIO2 CTCKE | Ergometrx, Inc. | Oct 18, 1993 | SESE |
Top Applicants
- Henley Intl. — 4 clearances
- Quinton, Inc. — 4 clearances
- Tri-Tech, Inc. — 4 clearances
- Biodan Medical Systems, Ltd. — 3 clearances
- Stanford Scientific, Inc. — 3 clearances
