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EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K163166
510(k) Type
Traditional
Applicant
EASYWELL BIOMEDICALS, INC.
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
8/11/2017
Days to Decision
270 days
Submission Type
Summary

EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K163166
510(k) Type
Traditional
Applicant
EASYWELL BIOMEDICALS, INC.
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
8/11/2017
Days to Decision
270 days
Submission Type
Summary