Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)— 510(k) K212285
Substantially EquivalentOriental Inspiration Limited
FDA 510(k) clearance K212285 for Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android), Substantially Equivalent on 2021-12-22. Applicant: Oriental Inspiration Limited. Device class: 2.
Clearance details
- Applicant
- Oriental Inspiration Limited
- 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
- Hong Kong, CN
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