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FDA 510(k)

Migraine Tens Digital Pain Reliever

K-Number: K210364 · 2021-06-17

ApplicantShenzhen Dongdixin Technology Co., Ltd.
Decision Date2021-06-17
Product CodePCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Migraine Tens Digital Pain Reliever is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-06-17 under 510(k) number K210364. The device is classified under product code PCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Migraine Tens Digital Pain Reliever?

Migraine Tens Digital Pain Reliever is a medical device that received FDA 510(k) clearance on 2021-06-17. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. The 510(k) number is K210364.

When did Migraine Tens Digital Pain Reliever receive FDA 510(k) clearance?

Migraine Tens Digital Pain Reliever received FDA 510(k) clearance on 2021-06-17, under 510(k) number K210364.

Who is the listed applicant for Migraine Tens Digital Pain Reliever?

The FDA 510(k) record lists Shenzhen Dongdixin Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Migraine Tens Digital Pain Reliever?

The FDA product code for Migraine Tens Digital Pain Reliever is PCC.

Other records listing Shenzhen Dongdixin Technology Co., Ltd. as applicant

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Related Devices (Code: PCC)

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.

K254216Enso for MigraineHinge Health, Inc.K242719ELEXIR 2.0 (ALLIVE3)Nu Eyne Co., Ltd.K234029CEFALY Connected - OTC, CEFALY Connected - RxCefaly TechnologyK232749DOOPANGYbrain, Inc.K233751Milieve (YPS-301BD)Soterix Medical, Inc.K230782TENS device-HeadaTerm 2 (Model: YF-HT2)Wat Medical Technology, Inc.

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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