Independence Technology, LLC: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Independence Technology, LLC” (first 2003, latest 2003), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 39 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 |
|---|---|---|---|
| IMK | Wheelchair, Stair Climbing | 1 | 0 |
| ITI | Wheelchair, Powered | 1 | 1 |
Review panels
Most recent Independence Technology, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K030250 | IGLIDE MANUAL ASSIST WHEELCHAIR | ITI | 2003-03-04 | 39 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P020033 | PMA | INDEPENDENCE (TM) IBOT 3000/4000 MOBILITY SYSTEM | 2003-08-13 |
Recalls
3 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2010-02-22.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Independence Technology, LLC?
FDA lists 1 510(k) clearance under the applicant name “Independence Technology, LLC” (first 2003, latest 2003), plus 1 PMA decision, across 2 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 Independence Technology, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Independence Technology, LLC is 39 days.
Which FDA product codes appear under Independence Technology, LLC?
The most frequent FDA product codes under this applicant name are IMK (Wheelchair, Stair Climbing, 1); ITI (Wheelchair, Powered, 1).
Next steps
- See all 1 Independence Technology, LLC clearances with predicates and recalls
- Run predicate analysis for product code IMK, Independence Technology, LLC'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.