FDA 510(k)
FDA class 1
Substantially Equivalent
🇦🇺 Australia
PUSH CUSH
K Number: K864108
·
Decision Nov 14, 1986
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
28
Applicant Total
19
Review Days
24
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Basic Information
- Device Name
- PUSH CUSH
- K Number
- K864108
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3175
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Medical Industries America, Inc.
- Date Received
- October 21, 1986
- Decision Date
- November 14, 1986
- 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 Medical Industries America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K050990 | REMREST HEATED HUMIDIFIER | May 2, 2005 | Substantially Equivalent |
| K032170 | TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000 | May 28, 2004 | Substantially Equivalent |
| K002763 | REMREST | May 4, 2001 | Substantially Equivalent |
| K011053 | OPTIMA | Apr 20, 2001 | Substantially Equivalent |
| K964078 | 3050 SPORT-NEB | Jan 10, 1997 | Substantially Equivalent |
| K943990 | 3000 AEROSOL TWO | Mar 21, 1995 | Substantially Equivalent |
| K942444 | 3002 AEROMAX | Mar 10, 1995 | Substantially Equivalent |
| K941961 | 605 VACU-MAX | Mar 2, 1995 | Substantially Equivalent |
| K942208 | 4003 AEROLITE | Feb 24, 1995 | Substantially Equivalent |
| K940630 | 503 MAXI COMPRESSOR | Feb 21, 1995 | Substantially Equivalent |