The following data is part of a premarket notification filed by Fujisawa Electronics Co. with the FDA for Tens Max.
| Device ID | K823388 |
| 510k Number | K823388 |
| Device Name: | TENS MAX |
| Classification | Fibrinogen Determination Standards And Controls |
| Applicant | FUJISAWA ELECTRONICS CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GFK |
| CFR Regulation Number | 864.7340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-15 |
| Decision Date | 1983-01-08 |