Pride Health Care, Inc.: FDA clearances and approvals
Pride Health Care, Inc. has 19 FDA 510(k) clearances (first 1988, latest 1996), across 5 product codes in 1 review panel. Median 510(k) review time: 120 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| INI | Vehicle, Motorized 3-Wheeled | 14 | 14 |
| INO | Chair, Positioning, Electric | 2 | 2 |
| ILK | Transport, Patient, Powered | 1 | 1 |
| INN | Chair, Adjustable, Mechanical | 1 | 1 |
| ITI | Wheelchair, Powered | 1 | 1 |
Review panels
- Physical Medicine (19)
Most recent Pride Health Care, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K945936 | JAZZY | ITI | 1996-05-28 | 540 |
| K944940 | EURO SC500 | INI | 1996-02-12 | 493 |
| K953342 | TMR48 | INO | 1995-09-08 | 59 |
| K944277 | DYNAMO | INI | 1994-12-28 | 120 |
| K944939 | CELEBRITY XL SC445 | INI | 1994-11-07 | 31 |
| K931231 | SIDEKICK II | INI | 1994-05-05 | 421 |
| K930953 | CELEBRITY SC440 | INI | 1994-03-28 | 398 |
| K930952 | PRIDE LEGEND SC-340 | INI | 1994-03-28 | 398 |
| K926499 | SHUTTLE SC-140 | INI | 1994-03-28 | 454 |
| K926296 | CELEBRITY SC400 | INI | 1994-03-28 | 469 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pride Health Care, Inc..
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 Pride Health Care, Inc. have?
Pride Health Care, Inc. has 19 FDA 510(k) clearances (first 1988, latest 1996), across 5 product codes in 1 review panel.
How long does FDA take to clear Pride Health Care, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Pride Health Care, Inc.'s cleared 510(k)s is 120 days.
What devices does Pride Health Care, Inc. make?
Its most frequent FDA product codes are INI (Vehicle, Motorized 3-Wheeled, 14); INO (Chair, Positioning, Electric, 2); ILK (Transport, Patient, Powered, 1).
Has Pride Health Care, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Pride Health Care, Inc. Related entities may recall under other names.
Next steps
- See all 19 Pride Health Care, Inc. clearances with predicates and recalls
- Run predicate analysis for product code INI, Pride Health Care, Inc.'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.