Warepalmy Enterprise, LLC (Usa): FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Warepalmy Enterprise, LLC (Usa)” (first 1998, latest 2001), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 65 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 | 6 | 6 |
| ITI | Wheelchair, Powered | 1 | 1 |
Review panels
Most recent Warepalmy Enterprise, LLC (Usa) 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K012792 | C.T.M. MOBITIY SCOOTER MODEL #HS-360 | INI | 2001-10-24 | 65 |
| K012791 | C.T.M. MOBILITY SCOOTER MODEL # HS-320 | INI | 2001-10-24 | 65 |
| K002983 | C.T.M. POWER CHAIR, MODEL HS-5600 | ITI | 2000-10-11 | 16 |
| K000356 | C.T.M. MOBILITY SCOOTER, MODEL H2-686, HS-740, HS-580 | INI | 2000-08-25 | 203 |
| K000354 | C.T.M. MOBILITY SCOOTERS HS-666, HS-730, HS-570 | INI | 2000-08-25 | 203 |
| K983663 | C.T.M. MOBILITY SCOOTER, MODEL # HS-666 | INI | 1998-12-18 | 60 |
| K983662 | C.T.M. MOBILITY SCOOTER, MODEL # HS-686 | INI | 1998-12-18 | 60 |
Recalls
openFDA lists no recalls under a recalling firm named Warepalmy Enterprise, LLC (Usa).
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 Warepalmy Enterprise, LLC (Usa)?
FDA lists 7 510(k) clearances under the applicant name “Warepalmy Enterprise, LLC (Usa)” (first 1998, latest 2001), 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 Warepalmy Enterprise, LLC (Usa)?
The median time from FDA receipt to decision across 510(k)s cleared under the name Warepalmy Enterprise, LLC (Usa) is 65 days.
Which FDA product codes appear under Warepalmy Enterprise, LLC (Usa)?
The most frequent FDA product codes under this applicant name are INI (Vehicle, Motorized 3-Wheeled, 6); ITI (Wheelchair, Powered, 1).
Next steps
- See all 7 Warepalmy Enterprise, LLC (Usa) clearances with predicates and recalls
- Run predicate analysis for product code INI, Warepalmy Enterprise, LLC (Usa)'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.