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FDA 510(k)

300 PV COMPLETE ELECTROTHERAPY SYSTEM

K-Number: K021100 · 2002-06-18

ApplicantEmpi
Decision Date2002-06-18
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

300 PV COMPLETE 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 2002-06-18 under 510(k) number K021100. 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 300 PV COMPLETE ELECTROTHERAPY SYSTEM?

300 PV COMPLETE ELECTROTHERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 2002-06-18. The listed applicant is Empi. The 510(k) number is K021100.

When did 300 PV COMPLETE ELECTROTHERAPY SYSTEM receive FDA 510(k) clearance?

300 PV COMPLETE ELECTROTHERAPY SYSTEM received FDA 510(k) clearance on 2002-06-18, under 510(k) number K021100.

Who is the listed applicant for 300 PV COMPLETE 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 300 PV COMPLETE ELECTROTHERAPY SYSTEM?

The FDA product code for 300 PV COMPLETE 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 4600SK041920INFINITY PLUS 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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