FDA product code IKK: System, Isokinetic Testing And Evaluation
IKK is the FDA product code for system, isokinetic testing and evaluation. It is a Class II device, regulated under 21 CFR 890.1925 and reviewed by the Physical Medicine panel. FDA has cleared 61 510(k) submissions under IKK, from 31 different applicants. The average 510(k) review took 94 days (median 45). FDA has posted 4 recalls for IKK devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Isokinetic Testing And Evaluation |
| Device class | Class II |
| Regulation | 21 CFR 890.1925 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IKK clearance
Top IKK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cybex | 7 | 1995-06-21 |
| Biodex Corp. | 7 | 1992-01-13 |
| Loredan Biomedical, Inc. | 7 | 1990-08-14 |
| Kent Design & Manufacturing, Inc. | 6 | 1986-08-20 |
| Biodan Medical Systems, Ltd. | 3 | 1992-07-23 |
26 more applicants have IKK clearances. See the full list in Caduvo.
Most recent IKK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K123746 | Ames Technology, Inc. | AMES THERAPY DEVICE | 2013-05-24 | 169 |
| K952090 | Computer Sports Medicine, Inc. | HUMAC SYSTEM | 1995-12-11 | 222 |
| K951770 | Biodex Medical Systems, Inc. | BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP | 1995-11-16 | 213 |
| K951916 | Mettler Electronics Corp. | CC RIDER, MODEL ME180 | 1995-10-04 | 163 |
| K950095 | Cybex | CYBEX 770 | 1995-06-21 | 162 |
Recalls for IKK devices
4 product recalls in 4 recall events; 1 initiated in the last five years and 2 still open. Most recent: 2023-05-31.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code IKK?
IKK is the FDA product code for system, isokinetic testing and evaluation. It is a Class II device, regulated under 21 CFR 890.1925 and reviewed by the Physical Medicine panel.
What device class is IKK?
Class II, regulation 21 CFR 890.1925. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IKK?
Across 61 cleared submissions the average was 94 days from receipt to decision (median 45).
Which companies have the most IKK clearances?
Cybex (7); Biodex Corp. (7); Loredan Biomedical, Inc. (7); Kent Design & Manufacturing, Inc. (6); Biodan Medical Systems, Ltd. (3).
Have IKK devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2023-05-31.
Next steps
- Run an FDA pathway report with predicate devices for product code IKK
- Run a recall and safety report across every IKK manufacturer
- Watch product code IKK 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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