FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
WHEELCHAIRS
K Number: K844574
·
Decision Feb 21, 1985
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
458
Applicant Total
14
Review Days
90
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Basic Information
- Device Name
- WHEELCHAIRS
- K Number
- K844574
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Medicon, Inc.
- Date Received
- November 23, 1984
- Decision Date
- February 21, 1985
- 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
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| K850855 | TENS GB1001 DEVICE | Jan 9, 1986 | Substantially Equivalent |
| K850852 | INFRARAX DEVICE | Aug 21, 1985 | Substantially Equivalent |
| K844702 | GAUZE ASORBABLE | Apr 1, 1985 | Substantially Equivalent |
| K844573 | ABSORBABLE GAUZE PRODUCTS | Mar 5, 1985 | Substantially Equivalent |
| K844705 | SHOE COVERS | Jan 10, 1985 | Substantially Equivalent |
| K844703 | GOWNS, SURGICAL | Jan 10, 1985 | Substantially Equivalent |
| K844704 | CAPS (O.R. NURSE, SURGICAL) | Jan 10, 1985 | Substantially Equivalent |
| K840034 | VACUUM STRETCHER IMMOBILIZER | Feb 27, 1984 | Substantially Equivalent |