FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SAFE-SEAT WHEELCHAIR CUSHION
K Number: K831247
·
Decision May 16, 1983
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
28
Applicant Total
4
Review Days
28
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Basic Information
- Device Name
- SAFE-SEAT WHEELCHAIR CUSHION
- K Number
- K831247
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3175
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- D.A. Schulman, Inc.
- Date Received
- April 18, 1983
- Decision Date
- May 16, 1983
- Product Code
- KIC
- 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 |
|---|---|---|---|
| KIC | Cushion, Flotation | FDA class 1 | Physical Medicine |
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