Comfort Orthopedic Co., Ltd.: FDA clearances and approvals
Comfort Orthopedic Co., Ltd. has 13 FDA 510(k) clearances (first 2002, latest 2010), across 4 product codes in 1 review panel. Median 510(k) review time: 81 days.
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 |
| IPL | Wheelchair, Standup | 3 | 3 |
| ITI | Wheelchair, Powered | 3 | 3 |
| IOR | Wheelchair, Mechanical | 1 | 1 |
Review panels
- Physical Medicine (13)
Most recent Comfort Orthopedic Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K102734 | COMFORT STANDING WHEELCHAIR, HERO SERIES | IPL | 2010-12-14 | 83 |
| K072712 | COMFORT ELECTRIC SCOOTER, LY-EW408 | INI | 2007-10-31 | 36 |
| K072711 | COMFORT POWERED WHEELCHAIR, LY-EB 206 | ITI | 2007-10-31 | 36 |
| K063030 | COMFORT SCOOTER MODEL LY-EW406 | INI | 2006-12-04 | 62 |
| K063032 | COMFORT SCOOTER, MODEL LY-EW415 | INI | 2006-10-16 | 13 |
| K031621 | HERO 1, MODEL LY-ESB220 | IPL | 2004-01-22 | 244 |
| K031618 | COMFORT VARIOUS OF STANDING WHEELCHAIR, HERO 2 | IPL | 2003-12-18 | 209 |
| K030356 | COMFORT POWERED WHEELCHAIR, TRAVELLER LY-EB 103 | ITI | 2003-05-20 | 106 |
| K030355 | COMFORT POWERED WHEELCHAIR, CONQUEROR LY-EB 202 | ITI | 2003-05-20 | 106 |
| K023581 | COMFORT AGILE SCOOTER, LY-EW303 | INI | 2002-12-02 | 39 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Comfort Orthopedic Co., Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Comfort Orthopedic Co., Ltd. have?
Comfort Orthopedic Co., Ltd. has 13 FDA 510(k) clearances (first 2002, latest 2010), across 4 product codes in 1 review panel.
How long does FDA take to clear Comfort Orthopedic Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Comfort Orthopedic Co., Ltd.'s cleared 510(k)s is 81 days.
What devices does Comfort Orthopedic Co., Ltd. make?
Its most frequent FDA product codes are INI (Vehicle, Motorized 3-Wheeled, 6); IPL (Wheelchair, Standup, 3); ITI (Wheelchair, Powered, 3).
Has Comfort Orthopedic Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Comfort Orthopedic Co., Ltd. Related entities may recall under other names.
Next steps
- See all 13 Comfort Orthopedic Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code INI, Comfort Orthopedic Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.