FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COMFORT STANDING WHEELCHAIR, HERO SERIES
K Number: K102734
·
Decision Dec 14, 2010
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
65
Applicant Total
13
Review Days
83
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- COMFORT STANDING WHEELCHAIR, HERO SERIES
- K Number
- K102734
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3900
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Comfort Orthopedic Co., Ltd.
- Date Received
- September 22, 2010
- Decision Date
- December 14, 2010
- Product Code
- IPL
- 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 |
|---|---|---|---|
| IPL | Wheelchair, Standup | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IPL), ordered by most recent decision date.
Walking rehabilitation training electric wheelchair (ZW518)
FDA 510(k)
FDA Class 2
·Physical Medicine
Action Trackchair Hawk
FDA 510(k)
FDA Class 2
·Physical Medicine
ParaMotion
FDA 510(k)
FDA Class 2
·Physical Medicine
Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08
FDA 510(k)
FDA Class 2
·Physical Medicine
Explorer Mini
FDA 510(k)
FDA Class 2
·Physical Medicine
F5 Corpus VS
FDA 510(k)
FDA Class 2
·Physical Medicine
Other Clearances by Comfort Orthopedic Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K030356 | COMFORT POWERED WHEELCHAIR, TRAVELLER LY-EB 103 | May 20, 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 |