The following data is part of a premarket notification filed by Axelgaard Mfg. Co., Ltd. with the FDA for Ultrastim Kit.
| Device ID | K013532 |
| 510k Number | K013532 |
| Device Name: | ULTRASTIM KIT |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | AXELGAARD MFG. CO., LTD. 1667 S. MISSION RD. Fallbrook, CA 92028 -4115 |
| Contact | Dan Jeffery |
| Correspondent | Dan Jeffery AXELGAARD MFG. CO., LTD. 1667 S. MISSION RD. Fallbrook, CA 92028 -4115 |
| Product Code | GZJ |
| Subsequent Product Code | GXY |
| Subsequent Product Code | IQE |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-17 |
| Decision Date | 2002-08-22 |