The following data is part of a premarket notification filed by Axelgaard Mfg. Co., Ltd. with the FDA for Ultrastim Electrode, Model Us4040.
| Device ID | K000947 |
| 510k Number | K000947 |
| Device Name: | ULTRASTIM ELECTRODE, MODEL US4040 |
| Classification | Electrode, Cutaneous |
| Applicant | AXELGAARD MFG. CO., LTD. 329 WEST AVIATION RD. Fallbrook, CA 92028 -3227 |
| Contact | Dan Jeffery |
| Correspondent | Dan Jeffery AXELGAARD MFG. CO., LTD. 329 WEST AVIATION RD. Fallbrook, CA 92028 -3227 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-23 |
| Decision Date | 2000-06-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852670007113 | K000947 | 000 |
| 00852670007106 | K000947 | 000 |
| 00852670007090 | K000947 | 000 |
| 00856817005970 | K000947 | 000 |
| 00856817005963 | K000947 | 000 |