Last synced on 17 May 2024 at 11:06 pm

Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222870
510(k) Type
Traditional
Applicant
Shenzhen Kentro Medical Electronics Co., Ltd
Country
China
FDA Decision
Substantially Equivalent
Decision Date
5/10/2023
Days to Decision
230 days
Submission Type
Summary

Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222870
510(k) Type
Traditional
Applicant
Shenzhen Kentro Medical Electronics Co., Ltd
Country
China
FDA Decision
Substantially Equivalent
Decision Date
5/10/2023
Days to Decision
230 days
Submission Type
Summary