FDA product code IPL: Wheelchair, Standup
IPL is the FDA product code for wheelchair, standup. It is a Class II device, regulated under 21 CFR 890.3900 and reviewed by the Physical Medicine panel. FDA has cleared 66 510(k) submissions under IPL, 3 in the last five years, from 51 different applicants. The average 510(k) review took 134 days (median 84); 93 days on average over the last three years. FDA has posted 1 recall for IPL devices.
Classification
| Field | Value |
|---|---|
| Device name | Wheelchair, Standup |
| Device class | Class II |
| Regulation | 21 CFR 890.3900 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for IPL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 280 |
| 2019 | 3 | 191 |
| 2020 | 2 | 362 |
| 2022 | 2 | 452 |
| 2025 | 1 | 93 |
Top IPL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Levo USA | 4 | 1997-12-23 |
| Comfort Orthopedic Co., Ltd. | 3 | 2010-12-14 |
| Levo AG | 3 | 2008-10-24 |
| Lifestand | 3 | 2006-12-04 |
| Action Manufacturing, Inc. | 2 | 2022-02-10 |
46 more applicants have IPL clearances. See the full list in Caduvo.
Most recent IPL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243783 | Shenzhen Zuowei Technology Co., Ltd. | Walking rehabilitation training electric wheelchair (ZW518) | 2025-03-12 | 93 |
| K202728 | Action Manufacturing, Inc. | Action Trackchair Hawk | 2022-02-10 | 510 |
| K203761 | Powerbasetec GmbH | ParaMotion | 2022-01-21 | 394 |
| K191334 | Matia Robotics (Us), Inc. | Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08 | 2020-05-29 | 378 |
| K190682 | Permobil AB | Explorer Mini | 2020-02-27 | 346 |
Recalls for IPL devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 0013-05-16.
Frequently asked questions
What is FDA product code IPL?
IPL is the FDA product code for wheelchair, standup. It is a Class II device, regulated under 21 CFR 890.3900 and reviewed by the Physical Medicine panel.
What device class is IPL?
Class II, regulation 21 CFR 890.3900. Typical premarket route: 510(k).
How long does a 510(k) take for product code IPL?
Across 66 cleared submissions the average was 134 days from receipt to decision (median 84).
Which companies have the most IPL clearances?
Levo USA (4); Comfort Orthopedic Co., Ltd. (3); Levo AG (3); Lifestand (3); Action Manufacturing, Inc. (2).
Have IPL devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 0013-05-16.
Next steps
- Run an FDA pathway report with predicate devices for product code IPL
- Run a recall and safety report across every IPL manufacturer
- Watch product code IPL 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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