FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RODEO MODEL, RD12, RD14, RD16, RADIO TRANSIT MODEL, RD12T, RD14T, RD16T,
K Number: K032402
·
Decision Sep 24, 2003
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
458
Applicant Total
8
Review Days
51
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Basic Information
- Device Name
- RODEO MODEL, RD12, RD14, RD16, RADIO TRANSIT MODEL, RD12T, RD14T, RD16T,
- K Number
- K032402
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Convaid Products, Inc.
- Date Received
- August 4, 2003
- Decision Date
- September 24, 2003
- Product Code
- IOR
- 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 |
|---|---|---|---|
| IOR | Wheelchair, Mechanical | FDA class 1 | Physical Medicine |
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Other Clearances by Convaid Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K140416 | TREKKER, TREKKER TRANSIT | Sep 17, 2014 | Substantially Equivalent |
| K120501 | CHAMP CHAMP TRANSIT | Sep 20, 2012 | Substantially Equivalent |
| K840250 | CARRIER | Feb 9, 1984 | Substantially Equivalent |
| K833195 | UMBRELLA WALKER | Oct 27, 1983 | Substantially Equivalent |
| K822992 | PEOPLE MOVER | Oct 27, 1982 | Substantially Equivalent |
| K810676 | CONVAID CRUISER CP4M | Mar 26, 1981 | Substantially Equivalent |
| K781947 | STROLLER, THERAPY | Dec 4, 1978 | Substantially Equivalent |