FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SOF. CARE CUSHION & SOF-CARE CUSHION COVER
K Number: K851027
·
Decision Jun 18, 1985
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
28
Applicant Total
27
Review Days
98
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Basic Information
- Device Name
- SOF. CARE CUSHION & SOF-CARE CUSHION COVER
- K Number
- K851027
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3175
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Gaymar Industries, Inc.
- Date Received
- March 12, 1985
- Decision Date
- June 18, 1985
- 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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Other Clearances by Gaymar Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K073675 | T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP | May 8, 2008 | Substantially Equivalent |
| K962788 | CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM | Apr 30, 1997 | Substantially Equivalent |
| K963067 | SOF. PRESS EPC 51 SYSTEM | Jan 28, 1997 | Substantially Equivalent |
| K961854 | SPR PLUS II OVERLAY SYSTEM (CL250/CL212 | Aug 9, 1996 | Substantially Equivalent |
| K942881 | TC 3000 | May 23, 1995 | Substantially Equivalent |
| K930345 | TC2000 POWER UNIT AND ACCESSORIES | Aug 6, 1993 | Substantially Equivalent |
| K914921 | SCM-3 AND ACCESSORIES | Mar 12, 1992 | Substantially Equivalent |
| K914805 | TC-1000, TC-1050 SYSTEM | Jan 7, 1992 | Substantially Equivalent |
| K914851 | CLA-1400 SYSTEM | Nov 13, 1991 | Substantially Equivalent |