The following data is part of a premarket notification filed by Vision Quest Industries, Inc. with the FDA for Fast Start Tens, Model Fs 3001.
| Device ID | K041092 |
| 510k Number | K041092 |
| Device Name: | FAST START TENS, MODEL FS 3001 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | VISION QUEST INDUSTRIES, INC. 18011 MITCHELL SO. Irvine, CA 92614 |
| Contact | Jaime X Pulley |
| Correspondent | Jaime X Pulley VISION QUEST INDUSTRIES, INC. 18011 MITCHELL SO. Irvine, CA 92614 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-26 |
| Decision Date | 2004-07-01 |
| Summary: | summary |