Last synced on 17 May 2024 at 11:06 pm

Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231423
510(k) Type
Traditional
Applicant
Shenzhen Roundwhale Technology Co. Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
1/22/2024
Days to Decision
250 days
Submission Type
Summary

Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231423
510(k) Type
Traditional
Applicant
Shenzhen Roundwhale Technology Co. Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
1/22/2024
Days to Decision
250 days
Submission Type
Summary