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Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180956
510(k) Type
Traditional
Applicant
Shenzhen Roundwhale Technology Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
6/7/2018
Days to Decision
56 days
Submission Type
Summary

Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180956
510(k) Type
Traditional
Applicant
Shenzhen Roundwhale Technology Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
6/7/2018
Days to Decision
56 days
Submission Type
Summary