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OTC TENS Device, Model PTS-IV

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161537
510(k) Type
Traditional
Applicant
COUNTER SCIENTIFIC DEVELOPMENT (GZ) LTD
Country
China
FDA Decision
Substantially Equivalent
Decision Date
10/13/2016
Days to Decision
132 days
Submission Type
Summary

OTC TENS Device, Model PTS-IV

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161537
510(k) Type
Traditional
Applicant
COUNTER SCIENTIFIC DEVELOPMENT (GZ) LTD
Country
China
FDA Decision
Substantially Equivalent
Decision Date
10/13/2016
Days to Decision
132 days
Submission Type
Summary