The following data is part of a premarket notification filed by Medical Technology Systems, Inc. with the FDA for Kalmate Model 3a.
| Device ID | K854476 |
| 510k Number | K854476 |
| Device Name: | KALMATE MODEL 3A |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | MEDICAL TECHNOLOGY SYSTEMS, INC. C/O COMPANION PRODUCTS INT'L 6985 VIA DEL ORO San Jose, CA 95119 |
| Contact | Robert Langstroth |
| Correspondent | Robert Langstroth MEDICAL TECHNOLOGY SYSTEMS, INC. C/O COMPANION PRODUCTS INT'L 6985 VIA DEL ORO San Jose, CA 95119 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-07 |
| Decision Date | 1986-02-27 |