Amigo Sales, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Amigo Sales, Inc.” (first 1980, latest 1987), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 29 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 |
|---|---|---|---|
| INI | Vehicle, Motorized 3-Wheeled | 3 | 3 |
| ITI | Wheelchair, Powered | 2 | 2 |
| INF | Scale, Platform, Wheelchair | 1 | 1 |
| INM | Chair, With Casters | 1 | 1 |
Review panels
Most recent Amigo Sales, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K871391 | AMIGO-A288310 (SCOOTER, COMMUTER CART, 3-WHEELED) | INF | 1987-05-06 | 29 |
| K853918 | THE SPORTSTER (ELECTRIFIED WHEELCHAIR) | INI | 1986-01-13 | 112 |
| K852557 | ALL TERRAIN AMIGO | INI | 1985-08-22 | 66 |
| K830345 | SCOOTER, VEHICLE MOTORIZED | INI | 1983-03-10 | 41 |
| K823117 | HITCH HIKER | ITI | 1982-11-16 | 26 |
| K820858 | ESCORT | INM | 1982-04-08 | 10 |
| K800209 | BOOTS - OUTDOOR CARRIER FOR THE AMIGO | ITI | 1980-02-22 | 21 |
Recalls
openFDA lists no recalls under a recalling firm named Amigo Sales, 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.
- Amigo Mobility Intl., Inc. (8 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Amigo Sales, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Amigo Sales, Inc.” (first 1980, latest 1987), across 4 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 Amigo Sales, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Amigo Sales, Inc. is 29 days.
Which FDA product codes appear under Amigo Sales, Inc.?
The most frequent FDA product codes under this applicant name are INI (Vehicle, Motorized 3-Wheeled, 3); ITI (Wheelchair, Powered, 2); INF (Scale, Platform, Wheelchair, 1).
Next steps
- See all 7 Amigo Sales, Inc. clearances with predicates and recalls
- Run predicate analysis for product code INI, Amigo Sales, 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.