FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Compex Wireless USA
K Number: K143551
·
Decision Apr 28, 2015
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
161
Applicant Total
12
Review Days
134
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Basic Information
- Device Name
- Compex Wireless USA
- K Number
- K143551
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Djo, LLC
- Date Received
- December 15, 2014
- Decision Date
- April 28, 2015
- Product Code
- NGX
- 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 |
|---|---|---|---|
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | FDA class 2 | Physical Medicine |
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|---|---|---|---|
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| K170903 | Compex Wireless USA | Jun 19, 2017 | Substantially Equivalent |
| K153704 | Strive | Jun 3, 2016 | Substantially Equivalent |
| K153696 | Chattanooga Revolution Wireless | Apr 14, 2016 | Substantially Equivalent |
| K153224 | VitalStim(R) Plus Electrotherapy System | Feb 17, 2016 | Substantially Equivalent |
| K132284 | VECTRA NEO CLINICAL THERAPY SYSTEM | Apr 10, 2014 | Substantially Equivalent |
| K130722 | AIRCAST VENAFLOW ELITE SYSTEM | Jun 20, 2013 | Substantially Equivalent |
| K124016 | EMPI PHOENIX | May 6, 2013 | Substantially Equivalent |
| K122499 | AIRCAST VENAFLOW ELITE SYSTEM | Oct 18, 2012 | Substantially Equivalent |