Comfort Orthopedic Co., Ltd.
Chia-Yi, TW
Comfort Orthopedic Co., Ltd. appears in FDA device records in Chia-Yi, TW. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Comfort Orthopedic Co., Ltd. between 2002 and 2010. The busiest year on record is 2002, with 4. The most recent is 2010, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 4 |
| 2003 | 3 |
| 2004 | 1 |
| 2006 | 2 |
| 2007 | 2 |
| 2010 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K102734 | COMFORT STANDING WHEELCHAIR, HERO SERIES | IPL | Substantially Equivalent | |
| K072712 | COMFORT ELECTRIC SCOOTER, LY-EW408 | INI | Substantially Equivalent | |
| K072711 | COMFORT POWERED WHEELCHAIR, LY-EB 206 | ITI | Substantially Equivalent | |
| K063030 | COMFORT SCOOTER MODEL LY-EW406 | INI | Substantially Equivalent | |
| K063032 | COMFORT SCOOTER, MODEL LY-EW415 | INI | Substantially Equivalent | |
| K031621 | HERO 1, MODEL LY-ESB220 | IPL | Substantially Equivalent | |
| K031618 | COMFORT VARIOUS OF STANDING WHEELCHAIR, HERO 2 | IPL | Substantially Equivalent | |
| K030356 | COMFORT POWERED WHEELCHAIR, TRAVELLER LY-EB 103 | ITI | Substantially Equivalent | |
| K030355 | COMFORT POWERED WHEELCHAIR, CONQUEROR LY-EB 202 | ITI | Substantially Equivalent | |
| K023581 | COMFORT AGILE SCOOTER, LY-EW303 | INI | Substantially Equivalent | |
| K022369 | COMFORT WINDJOY SCOOTER, MODEL LY-EW302 | INI | Substantially Equivalent | |
| K021910 | COMFORT DREAMRIDER SCOOTER, LY-EW402 | INI | Substantially Equivalent | |
| K020451 | COMFORT WHEELCHAIRS | IOR | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain