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FDA 510(k)

TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3

K-Number: K912015 · 1991-11-15

ApplicantEmpi
Decision Date1991-11-15
Product CodeEGJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3 is the device name listed in this FDA 510(k) record. The listed applicant is Empi. It received FDA 510(k) clearance on 1991-11-15 under 510(k) number K912015. The device is classified under product code EGJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3?

TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3 is a medical device that received FDA 510(k) clearance on 1991-11-15. The listed applicant is Empi. The 510(k) number is K912015.

When did TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3 receive FDA 510(k) clearance?

TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3 received FDA 510(k) clearance on 1991-11-15, under 510(k) number K912015.

Who is the listed applicant for TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3?

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

What is the FDA product code for TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3?

The FDA product code for TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3 is EGJ.

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Other records listing Empi 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.

K093324EMPI CONTINUUMK090922EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATORK072946HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEMK070427DUPEL TRANSPORT IONTOPHORESIS SYSTEMK061650SELECT TENS, MODEL 4600SK041920INFINITY PLUS ELECTROTHERAPY SYSTEM

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Related Devices (Code: EGJ)

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.

K242041STOPWET iontophoresis apparatus (SW01)Taiwan Medical Electronics Co., Ltd.K241267Hidroxa SE30Hidroxa Medical ABK232020Iontophoresis ElectrodesTop-Rank Health Care Co., Ltd.K192749DermadryDermadry Laboratories, Inc.K191436SaalioSaalmann Medical GmbH & Co. KGK170835Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITEHightech Development

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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