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FDA 510(k)

LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR

K-Number: K100117 · 2010-01-29

ApplicantShenzhen Dongdixin Technology Co., Ltd.
Decision Date2010-01-29
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR 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 2010-01-29 under 510(k) number K100117. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR?

LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR is a medical device that received FDA 510(k) clearance on 2010-01-29. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. The 510(k) number is K100117.

When did LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR receive FDA 510(k) clearance?

LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR received FDA 510(k) clearance on 2010-01-29, under 510(k) number K100117.

Who is the listed applicant for LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR?

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 LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR?

The FDA product code for LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR is IPF.

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Related Devices (Code: IPF)

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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