FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROVANT THERAPY SYSTEM
K Number: K131979
·
Decision Dec 13, 2013
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
14
Applicant Total
4
Review Days
168
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Basic Information
- Device Name
- PROVANT THERAPY SYSTEM
- K Number
- K131979
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5290
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Regenesis Biomedical, Inc.
- Date Received
- June 28, 2013
- Decision Date
- December 13, 2013
- Product Code
- ILX
- 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 |
|---|---|---|---|
| ILX | Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat | FDA class 2 | Physical Medicine |
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