Etac Us, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Etac Us, Inc.” (first 1988, latest 1993), across 1 product code in 1 review panel. Median 510(k) review time under this name: 36 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 |
Review panels
Most recent Etac Us, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K923428 | PANDA | IOR | 1993-03-04 | 234 |
| K914610 | SWEDE CROSS MANUAL WHEELCHAIR | IOR | 1991-11-29 | 43 |
| K883275 | SWEDE ELITE, MECHANICAL WHEELCHAIR | IOR | 1988-08-18 | 15 |
| K875035 | SWEDE PETITE (WHEELCHAIR) | IOR | 1988-01-12 | 36 |
| K875034 | SWEDE CHAMP (WHEELCHAIR) | IOR | 1988-01-12 | 36 |
Recalls
openFDA lists no recalls under a recalling firm named Etac Us, Inc..
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.
- Etac Sverige AB (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Etac Us, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Etac Us, Inc.” (first 1988, latest 1993), across 1 product code 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 Etac Us, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Etac Us, Inc. is 36 days.
Which FDA product codes appear under Etac Us, Inc.?
The most frequent FDA product codes under this applicant name are IOR (Wheelchair, Mechanical, 5).
Next steps
- See all 5 Etac Us, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IOR, Etac Us, Inc.'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.