TENS&EMS units (SM9109A, SM9109B)— 510(k) K241509
Substantially EquivalentPlexus Yoga, LLC Dba Chirp
FDA 510(k) clearance K241509 for TENS&EMS units (SM9109A, SM9109B), Substantially Equivalent on 2024-06-27. Applicant: Plexus Yoga, LLC Dba Chirp. Device class: 2.
Clearance details
- Applicant
- Plexus Yoga, LLC Dba Chirp
- 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
- Lehi, UT, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.