C.T.M. Homecare Product, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “C.T.M. Homecare Product, Inc.” (first 2002, latest 2011), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 38 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 | 11 | 11 |
| ITI | Wheelchair, Powered | 3 | 3 |
Review panels
- Physical Medicine (14)
Most recent C.T.M. Homecare Product, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K110567 | C.T.M. MOBILITY SCOOTER HS515(3W) | INI | 2011-04-22 | 53 |
| K110395 | C.T.M. MOBILITY SCOOTER - MODEL HS 118 | INI | 2011-04-22 | 70 |
| K091418 | C.T.M. MOBILITY SCOOTER, MODEL HS-628, INVACARE ORION | INI | 2009-07-06 | 54 |
| K090735 | C.T.M. MOBILITY SCOOTER, HS-528 | INI | 2009-07-06 | 109 |
| K073686 | C.T.M. POWER CHAIR, MODEL HS-1500 | ITI | 2008-02-27 | 61 |
| K070602 | C.T.M. MOBILITY SCOOTER# HS-265 | INI | 2007-04-02 | 28 |
| K070603 | C.T.M. MOBILITTY SCOOTER # HS-295 | INI | 2007-03-20 | 15 |
| K070025 | C.T.M. MOBILITY SCOOTER, MODEL HS-310 | INI | 2007-02-01 | 29 |
| K040020 | C.T.M. POWER CHAIR, MODEL HS-1000 | ITI | 2004-02-18 | 43 |
| K032919 | C.T.M. MOBILITY SCOOTER, MODEL HS-250 | INI | 2003-10-15 | 23 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named C.T.M. Homecare Product, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under C.T.M. Homecare Product, Inc.?
FDA lists 14 510(k) clearances under the applicant name “C.T.M. Homecare Product, Inc.” (first 2002, latest 2011), 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 C.T.M. Homecare Product, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name C.T.M. Homecare Product, Inc. is 38 days.
Which FDA product codes appear under C.T.M. Homecare Product, Inc.?
The most frequent FDA product codes under this applicant name are INI (Vehicle, Motorized 3-Wheeled, 11); ITI (Wheelchair, Powered, 3).
Next steps
- See all 14 C.T.M. Homecare Product, Inc. clearances with predicates and recalls
- Run predicate analysis for product code INI, C.T.M. Homecare Product, 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.