510(k) K210383
K210383 is an FDA 510(k) premarket notification submitted by Hi-Dow International, Inc. for the device "Wrap Accessory Electrodes". The FDA issued a decision of Substantially Equivalent on November 12, 2021. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Hi-Dow International, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 12, 2021
- Date Received
- February 9, 2021
- 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