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FDA 510(k)

MSLS6QF TENS/PMS Device

K-Number: K193655 · 2020-09-04

ApplicantSelf Doctor Care, LLC
Decision Date2020-09-04
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MSLS6QF TENS/PMS Device is a medical device manufactured by Self Doctor Care, LLC. It received FDA 510(k) clearance on 2020-09-04 under approval number K193655. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MSLS6QF TENS/PMS Device?

MSLS6QF TENS/PMS Device is a medical device that received FDA 510(k) clearance on 2020-09-04. It is manufactured by Self Doctor Care, LLC. The 510(k) number is K193655.

When was MSLS6QF TENS/PMS Device approved by the FDA?

MSLS6QF TENS/PMS Device received FDA 510(k) clearance on 2020-09-04, under approval number K193655.

What company makes MSLS6QF TENS/PMS Device?

MSLS6QF TENS/PMS Device is manufactured by Self Doctor Care, LLC.

What is the FDA product code for MSLS6QF TENS/PMS Device?

The FDA product code for MSLS6QF TENS/PMS Device is NUH.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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