FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Ampa One System (AMPA-001)
K Number: K251210
·
Decision Jun 27, 2025
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
65
Applicant Total
2
Review Days
70
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
- Ampa One System (AMPA-001)
- K Number
- K251210
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.5805
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neuromodulatory Devices & Applications
- Date Received
- April 18, 2025
- Decision Date
- June 27, 2025
- Product Code
- OBP
- Advisory Committee
- Neurology
- 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 |
|---|---|---|---|
| OBP | Transcranial Magnetic Stimulator | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OBP), ordered by most recent decision date.
MagVenture Accelerated TMS (aTMS) Therapy System
FDA 510(k)
FDA Class 2
·Neurology
Apollo TMS Therapy System;Apollo light TMS Therapy System
FDA 510(k)
FDA Class 2
·Neurology
Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
FDA 510(k)
FDA Class 2
·Neurology
Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
FDA 510(k)
FDA Class 2
·Neurology
SPRY TMS Therapy System (0550)
FDA 510(k)
FDA Class 2
·Neurology
BrainsWay Deep TMS System
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Neuromodulatory Devices & Applications
| K Number | Device Name | ||
|---|---|---|---|
| K243319 | Ampa One System (AMPA-001) | Feb 13, 2025 | Substantially Equivalent |