FDA product code IOQ: Bed, Flotation Therapy, Powered
IOQ is the FDA product code for bed, flotation therapy, powered. It is a Class II device, regulated under 21 CFR 890.5170 and reviewed by the Physical Medicine panel. FDA has cleared 57 510(k) submissions under IOQ, from 35 different applicants. The average 510(k) review took 101 days (median 70). FDA has posted 38 recalls for IOQ devices, 17 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Bed, Flotation Therapy, Powered |
| Device class | Class II |
| Regulation | 21 CFR 890.5170 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IOQ clearance
Top IOQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hill-Rom, Inc. | 5 | 1997-08-26 |
| Kinetic Concepts, Inc. | 5 | 1992-04-29 |
| Support Systems Intl. | 4 | 1995-02-10 |
| Bio Clinic Co. | 4 | 1993-07-21 |
| Gsi Development Co. | 3 | 1993-03-24 |
30 more applicants have IOQ clearances. See the full list in Caduvo.
Most recent IOQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K143414 | Hill-Rom | Hill-Rom Wireless Connectivity Module | 2015-03-10 | 102 |
| K122473 | Hill-Rom | TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2 | 2013-06-03 | 293 |
| K973624 | Air Med Assist Products | NURSE'S AID PATIENT ROTATION SYSTEM | 1998-01-21 | 120 |
| K970364 | Apex Metal, Inc. | AIRTEC2 LOW AIR LOSS THERAPY BED | 1997-11-17 | 290 |
| K970363 | Apex Metal, Inc. | HYDROTEC LOW AIR LOSS THERAPY BED | 1997-11-17 | 290 |
Recalls for IOQ devices
38 product recalls in 21 recall events; 17 initiated in the last five years and 15 still open. Most recent: 2026-08-18.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2022 | 9 |
| 2023 | 2 |
| 2024 | 2 |
| 2025 | 1 |
| 2026 | 3 |
Frequently asked questions
What is FDA product code IOQ?
IOQ is the FDA product code for bed, flotation therapy, powered. It is a Class II device, regulated under 21 CFR 890.5170 and reviewed by the Physical Medicine panel.
What device class is IOQ?
Class II, regulation 21 CFR 890.5170. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IOQ?
Across 57 cleared submissions the average was 101 days from receipt to decision (median 70).
Which companies have the most IOQ clearances?
Hill-Rom, Inc. (5); Kinetic Concepts, Inc. (5); Support Systems Intl. (4); Bio Clinic Co. (4); Gsi Development Co. (3).
Have IOQ devices been recalled?
Yes: 38 product recalls across 21 recall events; the most recent began 2026-08-18.
Next steps
- Run an FDA pathway report with predicate devices for product code IOQ
- Run a recall and safety report across every IOQ manufacturer
- Watch product code IOQ 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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