FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIO BOOST
K Number: K961426
·
Decision Oct 28, 1996
Classifications
1
FEI Numbers
95
Registration Numbers
95
Same Product Code
152
Applicant Total
15
Review Days
199
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Basic Information
- Device Name
- BIO BOOST
- K Number
- K961426
- 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
- April 12, 1996
- Decision Date
- October 28, 1996
- 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 |
Similar 510(k) Clearances
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Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1, LF-FT005-1, LF-FT006-1, LF-FT007, LF-FT008, LF-FT009, LF-FT010, LF-FT011, LF-FT012, LF-FT013, LF-FT014, LF-FT015, LF-FT016, UM-01, UM-02, UM-03, UM-03-1, UM-04-1, UM-05-1, UM-06-1, UM-07, UM-08, UM-09, UM-10, UM-11, UM-12, UM-13, UM-14, UM-15, UM-16, AI-01, AI-02, AI-03, AI-04, AI-05, AI-06, AI01, AI02, AI03, AI-07, AI-08, AI-09, AI-10, AI-11, AI-12, AI-13, AI-14)
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Other Clearances by Bio Compression Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| 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 |