FDA product code INO: Chair, Positioning, Electric
INO is the FDA product code for chair, positioning, electric. It is a Class II device, regulated under 21 CFR 890.3110 and reviewed by the Physical Medicine panel. FDA has cleared 53 510(k) submissions under INO, from 43 different applicants. The average 510(k) review took 84 days (median 56). FDA has posted 5 recalls for INO devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Chair, Positioning, Electric |
| Device class | Class II |
| Regulation | 21 CFR 890.3110 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every INO clearance
Top INO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Invacare Corp. | 4 | 2006-09-21 |
| Altimate Medical, Inc. | 2 | 2013-08-13 |
| Fresenius Medical Care South Asia Pacific Pty , Ltd. | 2 | 2011-12-30 |
| Pride Mobility Products Corp. | 2 | 2009-12-02 |
| Pride Health Care, Inc. | 2 | 1995-09-08 |
38 more applicants have INO clearances. See the full list in Caduvo.
Most recent INO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K131909 | Dalton Instrument Corp. | DALTON LIFT CHAIR | 2014-02-24 | 243 |
| K123834 | Altimate Medical, Inc. | EASYSTAND BANTAM MEDIUM | 2013-08-13 | 243 |
| K112944 | Fresenius Medical Care South Asia Pacific Pty , Ltd. | FRESENIUS MEDICAL TREATMENT CHAIR T688 SERIES | 2011-12-30 | 87 |
| K101723 | Design Specific Fletcher | COMPACT WHEELCHAIR PLATFORM | 2010-12-23 | 188 |
| K091578 | Pride Mobility Products Corp. | LIFT CHAIR, MODEL T3 | 2009-12-02 | 183 |
Recalls for INO devices
5 product recalls in 5 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-10-04.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code INO?
INO is the FDA product code for chair, positioning, electric. It is a Class II device, regulated under 21 CFR 890.3110 and reviewed by the Physical Medicine panel.
What device class is INO?
Class II, regulation 21 CFR 890.3110. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code INO?
Across 53 cleared submissions the average was 84 days from receipt to decision (median 56).
Which companies have the most INO clearances?
Invacare Corp. (4); Altimate Medical, Inc. (2); Fresenius Medical Care South Asia Pacific Pty , Ltd. (2); Pride Mobility Products Corp. (2); Pride Health Care, Inc. (2).
Have INO devices been recalled?
Yes: 5 product recalls across 5 recall events; the most recent began 2022-10-04.
Next steps
- Run an FDA pathway report with predicate devices for product code INO
- Run a recall and safety report across every INO manufacturer
- Watch product code INO 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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