FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POWERSTAND STAND-UP WHEELCHAIR
K Number: K032101
·
Decision Jan 22, 2004
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
65
Applicant Total
2
Review Days
198
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Basic Information
- Device Name
- POWERSTAND STAND-UP WHEELCHAIR
- K Number
- K032101
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3900
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- The Standing Co., Inc.
- Date Received
- July 8, 2003
- Decision Date
- January 22, 2004
- 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 |
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Other Clearances by The Standing Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K962278 | SUPERSTAND STAND-UP WHELLCHAIR | Oct 2, 1996 | Substantially Equivalent |