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Found 3 results

510(k) Data Aggregation

K Number

Device Name

ULTIMA TENS XL-A1

Manufacturer

TENS CARE LTD.

Date Cleared

2002-05-21

(67 days)

Product Code

GZJ

Regulation Number

882.5890

Why did this record match?

Applicant Name (Manufacturer) :

TENS CARE LTD.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

For the symptomatic relief of chronic intractable pain

Device Description

A portable TENS device for pain relief.

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K Number

Device Name

TENS CARE, MODEL XL-Y3

Manufacturer

TENS CARE LTD.

Date Cleared

2001-08-31

(105 days)

Product Code

GZJ

Regulation Number

882.5890

Why did this record match?

Applicant Name (Manufacturer) :

TENS CARE LTD.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

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K Number

Device Name

TENSCARE, MODEL TENS XL-2

Manufacturer

TENS CARE LTD.

Date Cleared

2001-02-14

(85 days)

Product Code

GZJ

Regulation Number

882.5890

Why did this record match?

Applicant Name (Manufacturer) :

TENS CARE LTD.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

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