FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
Compact II
K Number: K251083
·
Decision Sep 12, 2025
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
547
Applicant Total
5
Review Days
156
Basic Information
- Device Name
- Compact II
- K Number
- K251083
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Enraf-Nonius, B.V.
- Date Received
- April 9, 2025
- Decision Date
- September 12, 2025
- Product Code
- IPF
- 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 |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | FDA class 2 | Physical Medicine |
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Other Clearances by Enraf-Nonius, B.V.
| K Number | Device Name | ||
|---|---|---|---|
| K243112 | Curapuls 670 | Jun 25, 2025 | Substantially Equivalent |
| K230472 | Sonopuls 190 | Oct 24, 2023 | 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 |