FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
Sonopuls 190
K Number: K230472
·
Decision Oct 24, 2023
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
88
Applicant Total
5
Review Days
244
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Basic Information
- Device Name
- Sonopuls 190
- K Number
- K230472
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5300
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Enraf-Nonius, B.V.
- Date Received
- February 22, 2023
- Decision Date
- October 24, 2023
- Product Code
- IMI
- 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 |
|---|---|---|---|
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | FDA class 2 | Physical Medicine |
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Other Clearances by Enraf-Nonius, B.V.
| K Number | Device Name | ||
|---|---|---|---|
| K251083 | Compact II | Sep 12, 2025 | Substantially Equivalent |
| K243112 | Curapuls 670 | Jun 25, 2025 | Substantially Equivalent |
| K151640 | ELTRAC 471 | Oct 16, 2015 | Substantially Equivalent |
| K030297 | FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130 | Apr 28, 2003 | Substantially Equivalent |