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FDA 510(k)

Mytens Model: BW-TSX

K-Number: K171026 · 2017-11-01

ApplicantBewell Connect Corp.
Decision Date2017-11-01
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Mytens Model: BW-TSX is the device name listed in this FDA 510(k) record. The listed applicant is Bewell Connect Corp.. It received FDA 510(k) clearance on 2017-11-01 under 510(k) number K171026. 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 Mytens Model: BW-TSX?

Mytens Model: BW-TSX is a medical device that received FDA 510(k) clearance on 2017-11-01. The listed applicant is Bewell Connect Corp.. The 510(k) number is K171026.

When did Mytens Model: BW-TSX receive FDA 510(k) clearance?

Mytens Model: BW-TSX received FDA 510(k) clearance on 2017-11-01, under 510(k) number K171026.

Who is the listed applicant for Mytens Model: BW-TSX?

The FDA 510(k) record lists Bewell Connect Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mytens Model: BW-TSX?

The FDA product code for Mytens Model: BW-TSX 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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