FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
VenAir, Sequential Compression System
K Number: K213577
·
Decision Jun 28, 2022
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
349
Applicant Total
30
Review Days
230
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Basic Information
- Device Name
- VenAir, Sequential Compression System
- K Number
- K213577
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Apex Medical Corp.
- Date Received
- November 10, 2021
- Decision Date
- June 28, 2022
- 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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Other Clearances by Apex Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K193206 | WiZARD 510 Nasal Mask | Oct 29, 2020 | Substantially Equivalent |
| K182394 | WiZARD 310/320 Series CPAP Mask | May 17, 2019 | Substantially Equivalent |
| K150111 | Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series | Sep 15, 2015 | Substantially Equivalent |
| K141522 | APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES | Oct 6, 2014 | Substantially Equivalent |
| K121642 | WIZARD 230 NASAL PILOW MASK | Jun 6, 2013 | Substantially Equivalent |
| K112079 | APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720 | Dec 6, 2012 | Substantially Equivalent |
| K120035 | APEX MEDICAL ICH CPAP SERIES (9S-007XXX) | May 16, 2012 | Substantially Equivalent |
| K103174 | APEX MEDICAL WIZARD SERIES CPAP MASK | May 6, 2011 | Substantially Equivalent |
| K103535 | VACPLUS SUCTION UNIT | Feb 24, 2011 | Substantially Equivalent |
| K083656 | APEX MEDICAL XT AUTO CPAP 9S-005200 | Apr 22, 2009 | Substantially Equivalent |