The following data is part of a premarket notification filed by Bionicare Medical Technologies, Inc. with the FDA for Modification To Bionicare Stimulator System, Model Bio-1000.
| Device ID | K030332 |
| 510k Number | K030332 |
| Device Name: | MODIFICATION TO 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-31 |
| Decision Date | 2003-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817717021668 | K030332 | 000 |
| 00817717020135 | K030332 | 000 |
| 00817717020142 | K030332 | 000 |
| 00817717020159 | K030332 | 000 |
| 00817717020166 | K030332 | 000 |
| 00817717020173 | K030332 | 000 |
| 00817717020180 | K030332 | 000 |
| 00817717020197 | K030332 | 000 |
| 00817717020203 | K030332 | 000 |
| 00817717020210 | K030332 | 000 |
| 00817717020227 | K030332 | 000 |
| 00817717020234 | K030332 | 000 |
| 00817717020241 | K030332 | 000 |
| 00817717020128 | K030332 | 000 |