FDA product code IOL: Treadmill, Powered
IOL is the FDA product code for treadmill, powered. It is a Class I device, regulated under 21 CFR 890.5380 and reviewed by the Physical Medicine panel. FDA has cleared 43 510(k) submissions under IOL, from 24 different applicants. The average 510(k) review took 66 days (median 41). FDA has posted 19 recalls for IOL devices, 14 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Treadmill, Powered |
| Device class | Class I |
| Regulation | 21 CFR 890.5380 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Top IOL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Quinton, Inc. | 9 | 1991-05-29 |
| Battle Creek Equipment Co. | 3 | 1985-12-27 |
| Eaton Medical Group | 3 | 1985-07-15 |
| Burdick Corp. | 3 | 1980-01-04 |
| Parker Treadmill Co., Inc. | 2 | 1995-09-06 |
19 more applicants have IOL clearances. See the full list in Caduvo.
Most recent IOL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K950376 | Parker Treadmill Co., Inc. | PARKER MODEL PM | 1995-09-06 | 218 |
| K950377 | Parker Treadmill Co., Inc. | PARKER MODEL PE | 1995-09-06 | 218 |
| K925839 | Jas Manufacturing Co., Inc. | TRACKMASTER | 1993-06-24 | 218 |
| K930261 | Biodan Medical Systems, Ltd. | RTM REHABILITATION TREADMILL, MODEL #945-200 | 1993-05-26 | 127 |
| K904556 | Boston Scientific Corp | MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB | 1991-12-18 | 439 |
Recalls for IOL devices
19 product recalls in 7 recall events; 14 initiated in the last five years and 14 still open. Most recent: 2023-05-12.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2022 | 7 |
| 2023 | 7 |
Frequently asked questions
What is FDA product code IOL?
IOL is the FDA product code for treadmill, powered. It is a Class I device, regulated under 21 CFR 890.5380 and reviewed by the Physical Medicine panel.
What device class is IOL?
Class I, regulation 21 CFR 890.5380. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IOL?
Across 43 cleared submissions the average was 66 days from receipt to decision (median 41).
Which companies have the most IOL clearances?
Quinton, Inc. (9); Battle Creek Equipment Co. (3); Eaton Medical Group (3); Burdick Corp. (3); Parker Treadmill Co., Inc. (2).
Have IOL devices been recalled?
Yes: 19 product recalls across 7 recall events; the most recent began 2023-05-12.
Next steps
- Run an FDA pathway report with predicate devices for product code IOL
- Run a recall and safety report across every IOL manufacturer
- Watch product code IOL 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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