The following data is part of a premarket notification filed by Wandy Rubber Industrial Co., Ltd with the FDA for Wandy Silicone Conductive Rubber Pad.
| Device ID | K002227 |
| 510k Number | K002227 |
| Device Name: | WANDY SILICONE CONDUCTIVE RUBBER PAD |
| Classification | Electrode, Cutaneous |
| Applicant | WANDY RUBBER INDUSTRIAL CO., LTD NO. 22, ALLAY 37, LANE 266 FU TEH I RD. Shi-chih, Taipei, TW |
| Contact | Janis Yang |
| Correspondent | Janis Yang WANDY RUBBER INDUSTRIAL CO., LTD NO. 22, ALLAY 37, LANE 266 FU TEH I RD. Shi-chih, Taipei, TW |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-24 |
| Decision Date | 2001-02-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861284002629 | K002227 | 000 |
| 00861284002612 | K002227 | 000 |
| B312C51400 | K002227 | 000 |
| B312C51300 | K002227 | 000 |
| B312C51200 | K002227 | 000 |
| B243PSRCR552 | K002227 | 000 |
| B243PSRCR2102 | K002227 | 000 |
| 00861284002636 | K002227 | 000 |