The following data is part of a premarket notification filed by Advanced Medical Products, Inc. with the FDA for Advanced Medical Products Dr Pulse (tens).
| Device ID | K852837 |
| 510k Number | K852837 |
| Device Name: | ADVANCED MEDICAL PRODUCTS DR PULSE (TENS) |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | ADVANCED MEDICAL PRODUCTS, INC. 384 PRATT ST. Meriden, CT 06450 |
| Contact | Charles A Garcia |
| Correspondent | Charles A Garcia ADVANCED MEDICAL PRODUCTS, INC. 384 PRATT ST. Meriden, CT 06450 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-02 |
| Decision Date | 1985-08-28 |