FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
High Tone Power therapy (HiToP) (Model: HiToP PNP)
K Number: K252816
·
Decision Jun 2, 2026
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
547
Applicant Total
1
Review Days
271
Basic Information
- Device Name
- High Tone Power therapy (HiToP) (Model: HiToP PNP)
- K Number
- K252816
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mohammadali Nezakati
- Date Received
- September 4, 2025
- Decision Date
- June 2, 2026
- Product Code
- IPF
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- NE
- 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
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
Quantum Mitohormesis (QMT) (M2101)
FDA 510(k)
FDA Class 2
·Physical Medicine