The following data is part of a premarket notification filed by Home Care Technology Co., Ltd. with the FDA for Home Care Various Models Of Self-adhesive Electrodes.
| Device ID | K022917 |
| 510k Number | K022917 |
| Device Name: | HOME CARE VARIOUS MODELS OF SELF-ADHESIVE ELECTRODES |
| Classification | Electrode, Cutaneous |
| Applicant | HOME CARE TECHNOLOGY CO., LTD. NO. 58, FU-CHIUN ST. POSTAL CODE 300 Hsin-chu City, TW 300 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min HOME CARE TECHNOLOGY CO., LTD. NO. 58, FU-CHIUN ST. POSTAL CODE 300 Hsin-chu City, TW 300 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-03 |
| Decision Date | 2003-03-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719873684755 | K022917 | 000 |
| 04719873684724 | K022917 | 000 |
| 04719873684328 | K022917 | 000 |