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 |