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FDA 510(k)

INFINITY PLUS ELECTROTHERAPY SYSTEM

K-Number: K041920 · 2005-01-21

ApplicantEmpi
Decision Date2005-01-21
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

INFINITY PLUS ELECTROTHERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Empi. It received FDA 510(k) clearance on 2005-01-21 under 510(k) number K041920. 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 INFINITY PLUS ELECTROTHERAPY SYSTEM?

INFINITY PLUS ELECTROTHERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 2005-01-21. The listed applicant is Empi. The 510(k) number is K041920.

When did INFINITY PLUS ELECTROTHERAPY SYSTEM receive FDA 510(k) clearance?

INFINITY PLUS ELECTROTHERAPY SYSTEM received FDA 510(k) clearance on 2005-01-21, under 510(k) number K041920.

Who is the listed applicant for INFINITY PLUS ELECTROTHERAPY SYSTEM?

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 INFINITY PLUS ELECTROTHERAPY SYSTEM?

The FDA product code for INFINITY PLUS ELECTROTHERAPY SYSTEM is IPF.

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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 4600SK042057INFINITY ELECTROTHERAPY SYSTEM

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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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