Data / Medical devices / United States / Bioelectronics Corporation
Bioelectronics Corporation: FDA-registered device maker in Jefferson, MD, United States, 2 510(k) clearances
Bioelectronics Corporation is registered with the FDA (registration 3004837702) in Jefferson, MD, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 31, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004837702
- FEI number
- 3005550216
- Address
- 3880 Roundtree Rd Unit 1, Jefferson, MD, United States, 21755
- Owner or operator
- BioElectronics Corporation (10028114)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- December 31, 2019
- Registered through
- 2026
- Brand names listed
- ActiPatch® Model 077, ActiPatch® Model 088, RecoveryRx Model 077, RecoveryRx Model 088
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat | ILX | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain | PQY | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 31, 2020 | K192234 | ActiPatch | PQY | Substantially Equivalent | Bioelectronics Corporation | accessdata.fda.gov |
| June 28, 2019 | K190251 | RecoveryRx | ILX | Substantially Equivalent | Bioelectronics Corporation | accessdata.fda.gov |
Compare with other makers
Updated January 31, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.