The following data is part of a premarket notification filed by Oms Medical Supplies, Inc. with the FDA for Pointer F-3 Tens.
| Device ID | K904388 |
| 510k Number | K904388 |
| Device Name: | POINTER F-3 TENS |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | OMS MEDICAL SUPPLIES, INC. 230 LIBBEY PKWY. Weymouth, MA 02189 |
| Contact | Thomas Riihimaki |
| Correspondent | Thomas Riihimaki OMS MEDICAL SUPPLIES, INC. 230 LIBBEY PKWY. Weymouth, MA 02189 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-25 |
| Decision Date | 1991-06-04 |