The following data is part of a premarket notification filed by Medical Design & Manufacturing Corp. with the FDA for Intercept T.e.n.s. Device.
| Device ID | K880492 |
| 510k Number | K880492 |
| Device Name: | INTERCEPT T.E.N.S. DEVICE |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | MEDICAL DESIGN & MANUFACTURING CORP. 929 EASTWIND DR. Westerville, OH 43081 |
| Contact | Michael Southworth |
| Correspondent | Michael Southworth MEDICAL DESIGN & MANUFACTURING CORP. 929 EASTWIND DR. Westerville, OH 43081 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-04 |
| Decision Date | 1988-04-18 |