FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ActiPatch
K Number: K192234
·
Decision Jan 31, 2020
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
1
Applicant Total
3
Review Days
165
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Basic Information
- Device Name
- ActiPatch
- K Number
- K192234
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5290
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bioelectronics Corporation
- Date Received
- August 19, 2019
- Decision Date
- January 31, 2020
- Product Code
- PQY
- 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 |
|---|---|---|---|
| PQY | Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PQY), ordered by most recent decision date.
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