The following data is part of a premarket notification filed by Axelgaard Mfg. Co., Ltd. with the FDA for Valuetrode.
| Device ID | K970426 |
| 510k Number | K970426 |
| Device Name: | VALUETRODE |
| Classification | Electrode, Cutaneous |
| Applicant | AXELGAARD MFG. CO., LTD. 329 W. AVIATION RD. Fallbrook, CA 92028 -3227 |
| Contact | Dan Jeffery |
| Correspondent | Dan Jeffery AXELGAARD MFG. CO., LTD. 329 W. 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 | 1997-02-04 |
| Decision Date | 1997-05-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861039000399 | K970426 | 000 |
| 00888912340816 | K970426 | 000 |
| 00888912340830 | K970426 | 000 |
| 00888912340847 | K970426 | 000 |
| 00888912340854 | K970426 | 000 |
| 00888912340861 | K970426 | 000 |
| 00888912340991 | K970426 | 000 |
| 00888912341004 | K970426 | 000 |
| 00888912341011 | K970426 | 000 |
| 00888912341028 | K970426 | 000 |
| 00888912341202 | K970426 | 000 |
| 15099058719004 | K970426 | 000 |
| 00861039000375 | K970426 | 000 |
| 00861039000382 | K970426 | 000 |
| 00888912023580 | K970426 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() VALUETRODE 75265577 not registered Dead/Abandoned |
AXELGAARD MANUFACTURING COMPANY, LTD. 1997-03-28 |