The following data is part of a premarket notification filed by Oms Medico, Inc. with the FDA for Uni-puls(tens) Model #292.
| Device ID | K865063 |
| 510k Number | K865063 |
| Device Name: | UNI-PULS(TENS) MODEL #292 |
| 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 | 1986-12-24 |
| Decision Date | 1987-03-17 |