510(k) K152432
- Device
- ActiPatch(R)
- Applicant
- BIOELECTRONICS CORPORATION
- 510(k) number
- K152432
- Product code
- PQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-02-03
- Date received
- 2015-08-27
- Regulation
- 890.5290
- Classification name
- Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANDREW WHELAN
- Address
- 4539 Metropolitan Ct. Frederick MD US 21704 21704
FDA Registration Numbers#
- 9611956
- 1511629
- 3004837702
- 3007282994
Source Documents#
Other 510(k) Records For Product Code PQY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K192234 | ActiPatch | Bioelectronics Corporation | 2020-01-31 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases