FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Stim2Go
K Number: K230701
·
Decision Nov 24, 2023
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
547
Applicant Total
44
Review Days
255
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Stim2Go
- K Number
- K230701
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PAJUNK GmbH Medizintechnologie
- Date Received
- March 14, 2023
- Decision Date
- November 24, 2023
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IPF), ordered by most recent decision date.
Apollo Quattro (APQ-10M)
FDA 510(k)
FDA Class 2
·Physical Medicine
High Tone Power therapy (HiToP) (Model: HiToP PNP)
FDA 510(k)
FDA Class 2
·Physical Medicine
StimelMD (SSMD) system
FDA 510(k)
FDA Class 2
·Physical Medicine
Compact II
FDA 510(k)
FDA Class 2
·Physical Medicine
EVE Synergy (EVE-20M)
FDA 510(k)
FDA Class 2
·Physical Medicine
TrainFES Advance
FDA 510(k)
FDA Class 2
·Physical Medicine
Other Clearances by PAJUNK GmbH Medizintechnologie
| K Number | Device Name | ||
|---|---|---|---|
| K243690 | SonoMSK | Jul 1, 2025 | Substantially Equivalent |
| K243682 | SonoPlex STIM; SonoPlex II | Jun 27, 2025 | Substantially Equivalent |
| K250774 | SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture | Jun 25, 2025 | Substantially Equivalent |
| K243525 | SonoTAP and SonoTAP II | Mar 24, 2025 | Substantially Equivalent |
| K241953 | SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology | Nov 22, 2024 | Substantially Equivalent |
| K241954 | SonoBlock; SonoBlock II | Sep 11, 2024 | Substantially Equivalent |
| K230201 | Disposable Pre-calibrated Brain Biopsy Needle 2.0 | Feb 22, 2023 | Substantially Equivalent |
| K220897 | Disposable Brain Biopsy Needle 2.0 | Aug 17, 2022 | Substantially Equivalent |
| K202699 | E-Cath STIM acc. Tsui | Dec 29, 2020 | Substantially Equivalent |
| K190663 | Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6 | Jun 17, 2019 | Substantially Equivalent |