510(k) K022917
K022917 is an FDA 510(k) premarket notification submitted by Home Care Technology Co., Ltd. for the device "HOME CARE VARIOUS MODELS OF SELF-ADHESIVE ELECTRODES". The FDA issued a decision of Substantially Equivalent on Mar 4, 2003. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Home Care Technology Co., Ltd. has 3 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 4, 2003
- Date Received
- Sep 3, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Electrode, Cutaneous
- Device Class
- Class II
- Regulation Number
- 882.1320
- Review Panel
- NE
- Submission Type
- 510(k)