FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Intermittent Pneumatic Compression system
K Number: K160180
·
Decision Nov 3, 2016
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
349
Applicant Total
14
Review Days
281
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Basic Information
- Device Name
- Intermittent Pneumatic Compression system
- K Number
- K160180
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.5800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Daesung Maref Co., Ltd.
- Date Received
- January 27, 2016
- Decision Date
- November 3, 2016
- Product Code
- JOW
- 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 |
|---|---|---|---|
| JOW | Sleeve, Limb, Compressible | FDA class 2 | Cardiovascular |
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VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr
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PlasmaFlow X Compression Sleeve Device (XPF0001)
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| K203016 | DVT-2600 | Dec 5, 2020 | Substantially Equivalent |
| K160178 | Lympha-Flow(LF1200) | Jan 11, 2017 | Substantially Equivalent |
| K150980 | Venous Assist System | May 12, 2016 | Substantially Equivalent |
| K150033 | Air Compressible Limb Therapy System | Apr 20, 2015 | Substantially Equivalent |