FDA product code IKZ: Bed, Patient Rotation, Powered
IKZ is the FDA product code for bed, patient rotation, powered. It is a Class II device, regulated under 21 CFR 890.5225 and reviewed by the Physical Medicine panel. FDA has cleared 17 510(k) submissions under IKZ, from 14 different applicants. The average 510(k) review took 128 days (median 91). FDA has posted 12 recalls for IKZ devices.
Classification
| Field | Value |
|---|---|
| Device name | Bed, Patient Rotation, Powered |
| Device class | Class II |
| Regulation | 21 CFR 890.5225 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IKZ clearance
Top IKZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kinetic Concepts, Inc. | 3 | 1991-01-08 |
| Hill-Rom, Inc. | 2 | 1998-02-02 |
| Span-America Medical Systems, Inc. | 1 | 1998-02-20 |
| Gaymar Industries, Inc. | 1 | 1997-04-30 |
| Probed Medical Technologies, Inc. | 1 | 1996-04-01 |
9 more applicants have IKZ clearances. See the full list in Caduvo.
Most recent IKZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K972486 | Span-America Medical Systems, Inc. | PRESSUREGUARD IV | 1998-02-20 | 233 |
| K972111 | Hill-Rom, Inc. | RUMORS DYNAMIC AIR THERAPY UNIT | 1998-02-02 | 242 |
| K962788 | Gaymar Industries, Inc. | CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM | 1997-04-30 | 287 |
| K954671 | Probed Medical Technologies, Inc. | THE FREEDOM BED | 1996-04-01 | 174 |
| K950756 | Hill-Rom, Inc. | PULMONEX DYNAMIC AIR THERAPY UNIT | 1995-05-30 | 102 |
Recalls for IKZ devices
12 product recalls in 10 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2021-09-10.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2021 | 2 |
Frequently asked questions
What is FDA product code IKZ?
IKZ is the FDA product code for bed, patient rotation, powered. It is a Class II device, regulated under 21 CFR 890.5225 and reviewed by the Physical Medicine panel.
What device class is IKZ?
Class II, regulation 21 CFR 890.5225. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IKZ?
Across 17 cleared submissions the average was 128 days from receipt to decision (median 91).
Which companies have the most IKZ clearances?
Kinetic Concepts, Inc. (3); Hill-Rom, Inc. (2); Span-America Medical Systems, Inc. (1); Gaymar Industries, Inc. (1); Probed Medical Technologies, Inc. (1).
Have IKZ devices been recalled?
Yes: 12 product recalls across 10 recall events; the most recent began 2021-09-10.
Next steps
- Run an FDA pathway report with predicate devices for product code IKZ
- Run a recall and safety report across every IKZ manufacturer
- Watch product code IKZ 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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