Fortress Litestyle: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Fortress Litestyle” (first 1991, latest 1991), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 20 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| IOR | Wheelchair, Mechanical | 5 | 5 |
| ITI | Wheelchair, Powered | 2 | 2 |
| INI | Vehicle, Motorized 3-Wheeled | 1 | 1 |
Review panels
Most recent Fortress Litestyle 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K910753 | FORTRESS MODEL SPIRIT 4-WHEEL POWER WHEELCHAIR | ITI | 1991-04-22 | 60 |
| K910751 | FORTRESS 1600ACV REAR WHEEL DRIVE SCOOTER | INI | 1991-04-22 | 60 |
| K910749 | FORTRESS MODEL 760-V 4 WHEEL POWER WHEELCHAIR | ITI | 1991-04-22 | 60 |
| K910747 | FORTRESS AEROEDGE 3-WHEEL MANUAL RACING WHEELCHAIR | IOR | 1991-03-21 | 28 |
| K910752 | FORTRESS LIBERTY MANUAL FOLDING WHEELCHAIR | IOR | 1991-03-05 | 12 |
| K910750 | FORTRESS CUSTOM MANUAL FOLDING WHEELCHAIR | IOR | 1991-03-05 | 12 |
| K910748 | FORTRESS EDGE MANUAL RIGID WHEELCHAIR | IOR | 1991-03-05 | 12 |
| K910746 | FORTRESS FREESTYLE II MANUAL FOLDING WHEELCHAIR | IOR | 1991-03-05 | 12 |
Recalls
openFDA lists no recalls under a recalling firm named Fortress Litestyle.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Fortress Scientific , Ltd. (27 510(k)s)
- Fortress Lite-Style Wheelchairs, Inc. (3 510(k)s)
- Fortress, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Fortress Litestyle?
FDA lists 8 510(k) clearances under the applicant name “Fortress Litestyle” (first 1991, latest 1991), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Fortress Litestyle?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fortress Litestyle is 20 days.
Which FDA product codes appear under Fortress Litestyle?
The most frequent FDA product codes under this applicant name are IOR (Wheelchair, Mechanical, 5); ITI (Wheelchair, Powered, 2); INI (Vehicle, Motorized 3-Wheeled, 1).
Next steps
- See all 8 Fortress Litestyle clearances with predicates and recalls
- Run predicate analysis for product code IOR, Fortress Litestyle's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.