FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
COMFORT POWERED WHEELCHAIR, TRAVELLER LY-EB 103
K Number: K030356
·
Decision May 20, 2003
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
580
Applicant Total
13
Review Days
106
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Basic Information
- Device Name
- COMFORT POWERED WHEELCHAIR, TRAVELLER LY-EB 103
- K Number
- K030356
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Comfort Orthopedic Co., Ltd.
- Date Received
- February 3, 2003
- Decision Date
- May 20, 2003
- Product Code
- ITI
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ITI | Wheelchair, Powered | FDA class 2 | Physical Medicine |
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Other Clearances by Comfort Orthopedic Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K102734 | COMFORT STANDING WHEELCHAIR, HERO SERIES | Dec 14, 2010 | Substantially Equivalent |
| K072712 | COMFORT ELECTRIC SCOOTER, LY-EW408 | Oct 31, 2007 | Substantially Equivalent |
| K072711 | COMFORT POWERED WHEELCHAIR, LY-EB 206 | Oct 31, 2007 | Substantially Equivalent |
| K063030 | COMFORT SCOOTER MODEL LY-EW406 | Dec 4, 2006 | Substantially Equivalent |
| K063032 | COMFORT SCOOTER, MODEL LY-EW415 | Oct 16, 2006 | Substantially Equivalent |
| K031621 | HERO 1, MODEL LY-ESB220 | Jan 22, 2004 | Substantially Equivalent |
| K031618 | COMFORT VARIOUS OF STANDING WHEELCHAIR, HERO 2 | Dec 18, 2003 | Substantially Equivalent |
| K030355 | COMFORT POWERED WHEELCHAIR, CONQUEROR LY-EB 202 | May 20, 2003 | Substantially Equivalent |
| K023581 | COMFORT AGILE SCOOTER, LY-EW303 | Dec 2, 2002 | Substantially Equivalent |
| K021910 | COMFORT DREAMRIDER SCOOTER, LY-EW402 | Oct 11, 2002 | Substantially Equivalent |