The following data is part of a premarket notification filed by Zmi Corp. with the FDA for Brindley & Smith Et-1000.
| Device ID | K915100 |
| 510k Number | K915100 |
| Device Name: | BRINDLEY & SMITH ET-1000 |
| Classification | Interferential Current Therapy |
| Applicant | ZMI CORP. 3FL., NO. 255 MING-HWA ROAD KAOHSIUNG, TAIWAN 804 Taiwan, HK |
| Contact | Will Zeigner |
| Correspondent | Will Zeigner ZMI CORP. 3FL., NO. 255 MING-HWA ROAD KAOHSIUNG, TAIWAN 804 Taiwan, HK |
| Product Code | LIH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-12 |
| Decision Date | 1992-09-14 |