R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator— 510(k) K181688
Substantially EquivalentShenzhen Roundwhale Technology Co. , Ltd.
FDA 510(k) clearance K181688 for R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator, Substantially Equivalent on 2018-09-07. Applicant: Shenzhen Roundwhale Technology Co. , Ltd..
Clearance details
- Applicant
- Shenzhen Roundwhale Technology Co. , Ltd.
- Product code
- Code IPF
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Data sourced from openFDA. This site is unofficial and independent of the FDA.