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Found 2 results

510(k) Data Aggregation

K Number

Device Name

PREMIER PLUS

Manufacturer

AMERICAN IMEX

Date Cleared

2004-01-07

(194 days)

Product Code

GZJ

Regulation Number

882.5890

Why did this record match?

Applicant Name (Manufacturer) :

AMERICAN IMEX

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Transcutaneous Electrical Nerve Stimulation devices are used for the symptomatic relief and management of chronic intractable pain and for the symptomatic relief of acute post traumatic pain problems.

Device Description

Not Found

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K Number

Device Name

PREMIER AP

Manufacturer

AMERICAN IMEX

Date Cleared

1998-09-22

(90 days)

Product Code

GZJ

Regulation Number

882.5890

Why did this record match?

Applicant Name (Manufacturer) :

AMERICAN IMEX

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Transcutaneous Electrical Nerve Stimulaton (TENS) devices are to be used for the symptomatic relief and management of chronic (long term) intractable pain and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain problems.

Device Description

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