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FDA 510(k)

FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR

K-Number: K113010 · 2012-12-21

ApplicantFamidoc Technology Co., Ltd.
Decision Date2012-12-21
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Famidoc Technology Co., Ltd.. It received FDA 510(k) clearance on 2012-12-21 under 510(k) number K113010. 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 FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR?

FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR is a medical device that received FDA 510(k) clearance on 2012-12-21. The listed applicant is Famidoc Technology Co., Ltd.. The 510(k) number is K113010.

When did FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR receive FDA 510(k) clearance?

FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR received FDA 510(k) clearance on 2012-12-21, under 510(k) number K113010.

Who is the listed applicant for FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR?

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

What is the FDA product code for FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR?

The FDA product code for FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR is IPF.

Related Clinical Trials

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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Other records listing Famidoc Technology Co., Ltd. as applicant

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.

K212918Heat StimPlusK113761INFRARED THERMOMETERK072641DIGITAL ELECTRONIC THERMOMETER, MODEL: FDTH-V0-1 THRU 4.K052849INFRARED THERMOMETER, FDIR-V1

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

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