Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500)— 510(k) K231423
Substantially EquivalentShenzhen Roundwhale Technology Co. , Ltd.
FDA 510(k) clearance K231423 for Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500), Substantially Equivalent on 2024-01-22. Applicant: Shenzhen Roundwhale Technology Co. , Ltd.. Device class: 2.
Clearance details
- Applicant
- Shenzhen Roundwhale Technology Co. , Ltd.
- Product code
- Code NUH
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
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