The following data is part of a premarket notification filed by Oms Medical Supplies, Inc. with the FDA for Tx-7 (tens) (ic-1107).
| Device ID | K884210 |
| 510k Number | K884210 |
| Device Name: | TX-7 (TENS) (IC-1107) |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | OMS MEDICAL SUPPLIES, INC. 1950 WASHINGTON ST. Braintree, MA 02184 |
| Contact | A Riihimaki |
| Correspondent | A Riihimaki OMS MEDICAL SUPPLIES, 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 | 1988-10-06 |
| Decision Date | 1988-12-12 |