FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
SLENDAIR 4000 COMPRESSION SYSTEM
K Number: K994057
·
Decision Mar 3, 2000
Classifications
1
FEI Numbers
95
Registration Numbers
95
Same Product Code
152
Applicant Total
10
Review Days
94
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Basic Information
- Device Name
- SLENDAIR 4000 COMPRESSION SYSTEM
- K Number
- K994057
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5650
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medical Compression Systems (Dbn) , Ltd.
- Date Received
- November 30, 1999
- Decision Date
- March 3, 2000
- Product Code
- IRP
- 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 |
|---|---|---|---|
| IRP | Massager, Powered Inflatable Tube | FDA class 2 | Physical Medicine |
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Other Clearances by Medical Compression Systems (Dbn) , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K160431 | ActiveCare Home | Jul 13, 2016 | Substantially Equivalent |
| K140755 | ACTIVECARE DVT, ACTIVECARE+SFT, AND ACTIVECARE+DTX SYSTEMS | May 8, 2014 | Substantially Equivalent |
| K113525 | ACTIVECARE DVT ACTIVECARE+SFT | Jan 31, 2012 | Substantially Equivalent |
| K110159 | ACTIVECARE SFT | May 12, 2011 | Substantially Equivalent |
| K060146 | ACTIVECARE ++ SYSTEM | Mar 8, 2006 | Substantially Equivalent |
| K023573 | WIZAIR COMPRESSION SYSTEM | Nov 21, 2002 | Substantially Equivalent |
| K012994 | WIZAIR DVT | Mar 27, 2002 | Substantially Equivalent |
| K002287 | WIZAIR COMPRESSION SYSTEM | Aug 25, 2000 | Substantially Equivalent |
| K993758 | PROAIR 3000 COMPRESSION SYSTEM | May 19, 2000 | Substantially Equivalent |