The following data is part of a premarket notification filed by Biomedical Design Instruments with the FDA for Electro-acuscope 85.
| Device ID | K883911 |
| 510k Number | K883911 |
| Device Name: | ELECTRO-ACUSCOPE 85 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | BIOMEDICAL DESIGN INSTRUMENTS 700 SOUTH FLOWER ST. 30TH FLOOR Los Angeles, CA 90017 |
| Contact | Kenneth J Purcell |
| Correspondent | Kenneth J Purcell BIOMEDICAL DESIGN INSTRUMENTS 700 SOUTH FLOWER ST. 30TH FLOOR Los Angeles, CA 90017 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-15 |
| Decision Date | 1990-02-02 |