Motion Concepts: FDA clearances and approvals
Motion Concepts has 9 FDA 510(k) clearances (first 1997, latest 2019), across 2 product codes in 1 review panel. Median 510(k) review time: 48 days. openFDA lists 1 product recall by a recalling firm named Motion Concepts.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 116 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 2 | 106 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Motion Concepts's cleared 510(k)s took a median 106 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 125 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ITI | Wheelchair, Powered | 8 | 8 |
| IPL | Wheelchair, Standup | 1 | 1 |
Review panels
Most recent Motion Concepts 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K191376 | Modular Power Standing System | IPL | 2019-08-13 | 82 |
| K182995 | Bariatric Power Positioning System (BPPS) | ITI | 2019-03-08 | 129 |
| K150574 | Modular Power Positioning System | ITI | 2015-06-30 | 116 |
| K023426 | TRX VERTICAL POSITIONER | ITI | 2002-11-21 | 41 |
| K021264 | TRZ-CG POWER POSITIONING SYSTEM WITH CENTER-OF-GRAVITY SHIFTING POWER TILT, RECLINE, AND POWER ELEVATING SEAT | ITI | 2002-07-30 | 99 |
| K994241 | TRX-CG POWER TILT AND RECLINE SYSTEM | ITI | 2000-01-13 | 29 |
| K990544 | TRX-CG POWER TILT AND RECLINE SYSTEM | ITI | 1999-04-08 | 45 |
| K981837 | TRX-CG CENTER-OF-GRAVITY SHIFTING POWER TILT AND RECLINE SYSTEMS | ITI | 1998-07-09 | 44 |
| K970521 | TRX POWER TILT AND RECLINE SYSTEM | ITI | 1997-03-31 | 48 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2014-08-28.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Motion Concepts have?
Motion Concepts has 9 FDA 510(k) clearances (first 1997, latest 2019), across 2 product codes in 1 review panel.
How long does FDA take to clear Motion Concepts's 510(k)s?
The median time from FDA receipt to decision across Motion Concepts's cleared 510(k)s is 48 days.
What devices does Motion Concepts make?
Its most frequent FDA product codes are ITI (Wheelchair, Powered, 8); IPL (Wheelchair, Standup, 1).
Has Motion Concepts had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Motion Concepts; the most recent began 2014-08-28. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 9 Motion Concepts clearances with predicates and recalls
- Run predicate analysis for product code ITI, Motion Concepts's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.