FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THERMOPULSE
K Number: K131926
·
Decision Jul 24, 2014
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
44
Applicant Total
6
Review Days
393
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Basic Information
- Device Name
- THERMOPULSE
- K Number
- K131926
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5290
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Ibramed Equipamentos Medicos
- Date Received
- June 26, 2013
- Decision Date
- July 24, 2014
- Product Code
- IMJ
- 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 |
|---|---|---|---|
| IMJ | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | FDA class 2 | Physical Medicine |
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Other Clearances by Ibramed Equipamentos Medicos
| K Number | Device Name | ||
|---|---|---|---|
| K210572 | Neurodyn V2.0, Neurodyn Aussie V2.0 | May 11, 2021 | Substantially Equivalent |
| K131917 | NEURODYN COMPACT, NEURODYN II | Apr 29, 2014 | Substantially Equivalent |
| K131309 | SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ | Jan 27, 2014 | Substantially Equivalent |
| K131629 | NEURODYN MULTIWAVE, AUSSIE SPORT | Nov 26, 2013 | Substantially Equivalent |
| K121369 | NEURODYN RUBY MUSCLE STIMULATOR, NEURODYN AUSSIE MUSCLE STIMULATOR | Dec 19, 2012 | Substantially Equivalent |