FDA product code ISD: Exerciser, Measuring
ISD is the FDA product code for exerciser, measuring. It is a Class II device, regulated under 21 CFR 890.5360 and reviewed by the Physical Medicine panel. FDA has cleared 61 510(k) submissions under ISD, from 42 different applicants. The average 510(k) review took 139 days (median 74). FDA has posted 2 recalls for ISD devices.
Classification
| Field | Value |
|---|---|
| Device name | Exerciser, Measuring |
| Device class | Class II |
| Regulation | 21 CFR 890.5360 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
510(k) clearances per year for ISD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 111 |
| 2020 | 1 | 82 |
Compare with all 510(k) review times · Search every ISD clearance
Top ISD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Quinton, Inc. | 4 | 1999-04-29 |
| Henley Intl. | 4 | 1994-05-05 |
| Tri-Tech, Inc. | 4 | 1991-12-17 |
| Biodan Medical Systems, Ltd. | 3 | 1992-06-19 |
| Stanford Scientific, Inc. | 3 | 1979-11-15 |
37 more applicants have ISD clearances. See the full list in Caduvo.
Most recent ISD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K202979 | Lode B.V. | MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra | 2020-12-21 | 82 |
| K183296 | Penumbra, Inc. | REAL Immersive System | 2019-03-18 | 111 |
| K143512 | Sleep Modus, Inc. | ActiSpec Activity Monitor | 2015-08-26 | 258 |
| K112121 | Ergoline GmbH | ERGOSELECT/GE | 2012-10-31 | 464 |
| K080545 | Actigraph, LLC | ACTITRAINER | 2008-07-24 | 148 |
Recalls for ISD devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-04-09.
Frequently asked questions
What is FDA product code ISD?
ISD is the FDA product code for exerciser, measuring. It is a Class II device, regulated under 21 CFR 890.5360 and reviewed by the Physical Medicine panel.
What device class is ISD?
Class II, regulation 21 CFR 890.5360. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ISD?
Across 61 cleared submissions the average was 139 days from receipt to decision (median 74).
Which companies have the most ISD clearances?
Quinton, Inc. (4); Henley Intl. (4); Tri-Tech, Inc. (4); Biodan Medical Systems, Ltd. (3); Stanford Scientific, Inc. (3).
Have ISD devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2015-04-09.
Next steps
- Run an FDA pathway report with predicate devices for product code ISD
- Run a recall and safety report across every ISD manufacturer
- Watch product code ISD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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