510(k) K221251
K221251 is an FDA 510(k) premarket notification submitted by Guangzhou Huakai Electronic Technology Co., Ltd. for the device "Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)". The FDA issued a decision of Substantially Equivalent on Jul 29, 2022. The device falls under product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter), a Class II device regulated under 21 CFR 882.5890.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 29, 2022
- Date Received
- May 2, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve, Transcutaneous, Over-The-Counter
- Device Class
- Class II
- Regulation Number
- 882.5890
- Review Panel
- NE
- Submission Type
- 510(k)
TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES