FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
K Number: K213533
·
Decision Feb 16, 2022
Classifications
1
FEI Numbers
95
Registration Numbers
95
Same Product Code
152
Applicant Total
15
Review Days
103
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Basic Information
- Device Name
- Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
- K Number
- K213533
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5650
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bio Compression Systems, Inc.
- Date Received
- November 5, 2021
- Decision Date
- February 16, 2022
- 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 Bio Compression Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K250974 | Bio Arterial Deluxe (IC-BAP-DX) | Dec 12, 2025 | Substantially Equivalent |
| K210417 | Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL | May 14, 2021 | Substantially Equivalent |
| K180248 | VascuEase IC-1200-WH | Aug 7, 2018 | Substantially Equivalent |
| K171793 | Sequential Circulator SC-2004FC-OC | Aug 17, 2017 | Substantially Equivalent |
| K150953 | Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC | Jul 16, 2015 | Substantially Equivalent |
| K142640 | Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model SC-2008-DL Sequential Circulator, Model SC-3008-DL Sequential Circulator | Nov 6, 2014 | Substantially Equivalent |
| K131306 | IC-1545-DL MULTI FLO DVT COMBO INTERMITTENT PNEUMATIC COMPRESSION DEVICE | Jul 22, 2013 | Substantially Equivalent |
| K131327 | BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM | Jul 18, 2013 | Substantially Equivalent |
| K122112 | 2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM | Apr 9, 2013 | Substantially Equivalent |
| K072666 | BIOARTERIAL PLUS, ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM | Nov 5, 2007 | Substantially Equivalent |