FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RelieVRx (Pico G3)
K Number: K251519
·
Decision Aug 13, 2025
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
5
Applicant Total
2
Review Days
89
Basic Information
- Device Name
- RelieVRx (Pico G3)
- K Number
- K251519
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5800
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Appliedvr
- Date Received
- May 16, 2025
- Decision Date
- August 13, 2025
- Product Code
- QRA
- Advisory Committee
- Neurology
- 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 |
|---|---|---|---|
| QRA | Virtual Reality Behavioral Therapy Device For Pain Relief | FDA class 2 | Neurology |
Similar 510(k) Clearances
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Other Clearances by Appliedvr
| K Number | Device Name | ||
|---|---|---|---|
| K243417 | RelieVRx | Dec 4, 2024 | Substantially Equivalent |