FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Compressible Limb and Circulation Therapy System, Model POWER-Q2300
K Number: K211283
·
Decision Sep 14, 2021
Classifications
1
FEI Numbers
95
Registration Numbers
95
Same Product Code
152
Applicant Total
5
Review Days
140
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Basic Information
- Device Name
- Compressible Limb and Circulation Therapy System, Model POWER-Q2300
- K Number
- K211283
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5650
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wonjin Mulsan Co., Ltd.
- Date Received
- April 27, 2021
- Decision Date
- September 14, 2021
- 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 Wonjin Mulsan Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K200660 | Compressible Limb and Circulation Therapy System | Mar 8, 2021 | Substantially Equivalent |
| K113275 | COMPRESSIBLE LIMB THERAPY SYSTEM | Feb 27, 2012 | Substantially Equivalent |
| K100656 | COMPRESSIBLE LIMB THERAPY SYSTEM MODEL WHF-324 (POWER-Q1000 PLUS) | May 26, 2010 | Substantially Equivalent |
| K080134 | COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM, MODEL WHF-314 (POWER-Q1000) | Jan 23, 2009 | Substantially Equivalent |