The following data is part of a premarket notification filed by Bionicare Medical Technologies, Inc. with the FDA for Bionicare Stimulator System, Model Bio-1000.
| Device ID | K052625 |
| 510k Number | K052625 |
| Device Name: | BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 |
| Classification | Stimulator, Electrical, Transcutaneous, For Arthritis |
| Applicant | BIONICARE MEDICAL TECHNOLOGIES, INC. 47 R LOVETON CIRCLE Sparks, MD 21152 |
| Contact | Kent Hoffman |
| Correspondent | Kent Hoffman BIONICARE MEDICAL TECHNOLOGIES, INC. 47 R LOVETON CIRCLE Sparks, MD 21152 |
| Product Code | NYN |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-23 |
| Decision Date | 2005-12-05 |
| Summary: | summary |