Medi-Direct TENS Pen— 510(k) K182671
Substantially EquivalentJkh USA, LLC
FDA 510(k) clearance K182671 for Medi-Direct TENS Pen, Substantially Equivalent on 2019-09-21. Applicant: Jkh USA, LLC. Device class: 2.
Clearance details
- Applicant
- Jkh USA, LLC
- 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
- Diamond Bar, CA, US
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More clearances from Jkh USA, LLC
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- K203635 — Patient Monitoring Cables
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- K202851 — Spo2 Sensor
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Data sourced from openFDA. This site is unofficial and independent of the FDA.