FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Flexitouch System
K Number: K153311
·
Decision Sep 14, 2016
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
0
Applicant Total
3
Review Days
302
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Basic Information
- Device Name
- Flexitouch System
- K Number
- K153311
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tactile Systems Technology, Inc. (Dba Tactile Medical)
- Date Received
- November 17, 2015
- Decision Date
- September 14, 2016
- Product Code
- PPS
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| PPS | Sleeve, Head And Neck, Compressible | FDA class 2 | Cardiovascular |