The following data is part of a premarket notification filed by Bioelectronics Corporation with the FDA for Actipatch(r).
| Device ID | K152432 |
| 510k Number | K152432 |
| Device Name: | ActiPatch(R) |
| Classification | Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain |
| Applicant | BIOELECTRONICS CORPORATION 4539 METROPOLITAN COURT Frederick, MD 21704 |
| Contact | Andrew Whelan |
| Correspondent | Andrew Whelan BIOELECTRONICS CORPORATION 4539 METROPOLITAN COURT Frederick, MD 21704 |
| Product Code | PQY |
| CFR Regulation Number | 890.5290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-27 |
| Decision Date | 2017-02-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851329005203 | K152432 | 000 |
| 00851329005159 | K152432 | 000 |
| 00851329005012 | K152432 | 000 |
| 00851329005128 | K152432 | 000 |