Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)— 510(k) K221251
Substantially EquivalentGuangzhou Huakai Electronic Technology Co., Ltd.
FDA 510(k) clearance K221251 for Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C), Substantially Equivalent on 2022-07-29. Applicant: Guangzhou Huakai Electronic Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Guangzhou Huakai Electronic Technology Co., Ltd.
- Product code
- Code NUH
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Guangzhou, CN
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Data sourced from openFDA. This site is unofficial and independent of the FDA.