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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 the device name listed in this FDA 510(k) record. The listed applicant is Self Doctor Care, LLC. It received FDA 510(k) clearance on 2020-09-04 under 510(k) 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. The listed applicant is Self Doctor Care, LLC. The 510(k) number is K193655.

When did MSLS6QF TENS/PMS Device receive FDA 510(k) clearance?

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

Who is the listed applicant for MSLS6QF TENS/PMS Device?

The FDA 510(k) record lists Self Doctor Care, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: NUH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260412TENS 7000 Rechargeable 4 Channel (TENS 7000H)Shenzhen Dongdixin Technology Co., Ltd.K260425TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)Hivox Biotek, Inc.K253896TENS/EMS device (GUSE01)Globalcare Medical Technology Co., Ltd.K253305TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)Shenzhen Jiantuo Electronics Co., Ltd.K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)Hong Qiangxing (Shenzhen) Electronics LimitedK251958VEINOPLUS BackDynapulse Medical

Official Source

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

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