The following data is part of a premarket notification filed by Oms Medico, Inc. with the FDA for Tx-4(tens) (sigma Tens).
| Device ID | K874550 |
| 510k Number | K874550 |
| Device Name: | TX-4(TENS) (SIGMA TENS) |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | OMS MEDICO, INC. 1950 WASHINGTON ST. Braintree, MA 02184 |
| Contact | James Paisner |
| Correspondent | James Paisner OMS MEDICO, INC. 1950 WASHINGTON ST. Braintree, MA 02184 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-04 |
| Decision Date | 1987-11-20 |