FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KIRO, WHEELCHAIR FOR CHILDREN
K Number: K862889
·
Decision Aug 13, 1986
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
458
Applicant Total
12
Review Days
22
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Basic Information
- Device Name
- KIRO, WHEELCHAIR FOR CHILDREN
- K Number
- K862889
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Mednet, Inc.
- Date Received
- July 22, 1986
- Decision Date
- August 13, 1986
- 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 |
Similar 510(k) Clearances
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ICON 35; ICON 45; ICON 60; ICON 30FAF
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K5 wheelchair (16 with swing-away footrest 18 with swing-away footrest 20 with swing-away footrest 16 with elevated foot rest(ELR) 18 with elevated foot rest(ELR) 20 with elevated foot rest(ELR))
FDA 510(k)
FDA Class 1
·Physical Medicine
Other Clearances by Mednet, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K955782 | MED-NET STOPCOCKS | Feb 21, 1996 | Substantially Equivalent |
| K862887 | UPHOLSTERED BUCKET SEAT | Aug 14, 1986 | Substantially Equivalent |
| K862883 | ORTHOPEDIC SEATS | Aug 14, 1986 | Substantially Equivalent |
| K862885 | CAR SEAT | Aug 14, 1986 | Substantially Equivalent |
| K862892 | CASTER CAR | Aug 14, 1986 | Substantially Equivalent |
| K862895 | TRICYCLES | Aug 13, 1986 | Substantially Equivalent |
| K862893 | VENTRAL STANDING UNIT | Aug 13, 1986 | Substantially Equivalent |
| K862894 | SCHOOLTABLE | Aug 13, 1986 | Substantially Equivalent |
| K862888 | PERAMBULATOR (STROLLER) | Aug 13, 1986 | Substantially Equivalent |
| K862890 | TOILET/SHOWER CHAIR | Aug 13, 1986 | Substantially Equivalent |