The following data is part of a premarket notification filed by Bioinduction Limited with the FDA for Acticare Ic And Tse.
| Device ID | K081835 |
| 510k Number | K081835 |
| Device Name: | ACTICARE IC AND TSE |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | BIOINDUCTION LIMITED 2300 MCDERMOTT ROAD SUITE 200-207 Plano, TX 75025 |
| Contact | Krista Oakes |
| Correspondent | Krista Oakes BIOINDUCTION LIMITED 2300 MCDERMOTT ROAD SUITE 200-207 Plano, TX 75025 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-27 |
| Decision Date | 2009-03-19 |
| Summary: | summary |