FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SIDEWINDER OMNI WHEELCHAIR DIRECT/POWER
K Number: K823175
·
Decision Nov 16, 1982
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
580
Applicant Total
48
Review Days
21
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Basic Information
- Device Name
- SIDEWINDER OMNI WHEELCHAIR DIRECT/POWER
- K Number
- K823175
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Kinetic Concepts, Inc.
- Date Received
- October 26, 1982
- Decision Date
- November 16, 1982
- 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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|---|---|---|---|
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| K020781 | WET CHAMBER | May 6, 2002 | Substantially Equivalent |
| K992448 | V.A.C. PLUS | Jan 18, 2000 | Substantially Equivalent |
| K972176 | HOME CARE BEAD BED | Jan 16, 1998 | Substantially Equivalent |
| K972549 | SIMPULSE | Nov 18, 1997 | Substantially Equivalent |