FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EVANTGARDE/ENDEAVOR POWERED WHEELCHAIR
K Number: K000739
·
Decision Oct 24, 2000
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
580
Applicant Total
6
Review Days
231
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Basic Information
- Device Name
- EVANTGARDE/ENDEAVOR POWERED WHEELCHAIR
- K Number
- K000739
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Otto Bock Orthopedic Industry, Inc.
- Date Received
- March 7, 2000
- Decision Date
- October 24, 2000
- 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 Otto Bock Orthopedic Industry, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K000678 | RAEBBITT/EVOLUTION POWERED WHEELCHAIR | Sep 18, 2000 | Substantially Equivalent |
| K000497 | VOYAGER/VIPER WHEELCHAIR | Mar 8, 2000 | Substantially Equivalent |
| K000602 | PROTEGE WHEELCHAIR | Mar 3, 2000 | Substantially Equivalent |
| K991590 | C-LEG (3C100) | Jul 8, 1999 | Substantially Equivalent |
| K951847 | AVANTGARDE | May 12, 1995 | Substantially Equivalent |