FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
WHEELCHAIR, MECHANICAL
K Number: K885330
·
Decision Feb 3, 1989
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
458
Applicant Total
12
Review Days
37
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Basic Information
- Device Name
- WHEELCHAIR, MECHANICAL
- K Number
- K885330
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Kaye Products, Inc.
- Date Received
- December 28, 1988
- Decision Date
- February 3, 1989
- 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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ICON 35; ICON 45; ICON 60; ICON 30FAF
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FDA 510(k)
FDA Class 1
·Physical Medicine
Other Clearances by Kaye Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K924848 | KAYE SCOOT-ABOUT, MODEL SB1 | Feb 12, 1993 | Substantially Equivalent |
| K923095 | KAYE MODEL KIAO PELVIC/THIGH STABILIZER | Jul 21, 1992 | Substantially Equivalent |
| K922061 | CHAIR, ADJUSTABLE, MECHANICAL | May 26, 1992 | Substantially Equivalent |
| K833869 | CHILD'S WALKER | Nov 29, 1983 | Substantially Equivalent |
| K830560 | EXERCISER, PASSIVE, NON MEASURING | Mar 9, 1983 | Substantially Equivalent |
| K830466 | BARS, PARALLEL, EXERCISE | Mar 9, 1983 | Substantially Equivalent |
| K820591 | MECHANICAL CHAIR | Mar 15, 1982 | Substantially Equivalent |
| K812399 | CHAIR, ADJUSTABLE, MECHANICAL | Sep 14, 1981 | Substantially Equivalent |
| K812319 | THERAPY BENCH | Aug 31, 1981 | Substantially Equivalent |
| K810609 | PEDIATRIC POSITION HOLDER | Mar 20, 1981 | Substantially Equivalent |