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FDA 510(k)

DX6605E-TENS, DX6605E-G, DX6609-G

K-Number: K082057 · 2009-02-26

ApplicantShenzhen Dongdixin Technology Co., Ltd.
Decision Date2009-02-26
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DX6605E-TENS, DX6605E-G, DX6609-G 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 2009-02-26 under 510(k) number K082057. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DX6605E-TENS, DX6605E-G, DX6609-G?

DX6605E-TENS, DX6605E-G, DX6609-G is a medical device that received FDA 510(k) clearance on 2009-02-26. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. The 510(k) number is K082057.

When did DX6605E-TENS, DX6605E-G, DX6609-G receive FDA 510(k) clearance?

DX6605E-TENS, DX6605E-G, DX6609-G received FDA 510(k) clearance on 2009-02-26, under 510(k) number K082057.

Who is the listed applicant for DX6605E-TENS, DX6605E-G, DX6609-G?

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 DX6605E-TENS, DX6605E-G, DX6609-G?

The FDA product code for DX6605E-TENS, DX6605E-G, DX6609-G is GZJ.

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

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Related Devices (Code: GZJ)

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.

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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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