The following data is part of a premarket notification filed by Fuching Enterprise Co., Ltd. with the FDA for Purecare At-903 T.e.n.s..
| Device ID | K931715 |
| 510k Number | K931715 |
| Device Name: | PURECARE AT-903 T.E.N.S. |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | FUCHING ENTERPRISE CO., LTD. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
| Contact | Alan P Schwartz |
| Correspondent | Alan P Schwartz FUCHING ENTERPRISE CO., LTD. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-06 |
| Decision Date | 1994-01-27 |