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Found 2 results

510(k) Data Aggregation

K Number

Device Name

MS-ONE, MODEL MS-1

Manufacturer

HOME WELLNESS WEST

Date Cleared

2001-01-12

(86 days)

Product Code

Regulation Number

Why did this record match?

Applicant Name (Manufacturer) :

HOME WELLNESS WEST

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty

Intended Use

Device Description

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K Number

Device Name

MS-ONE, MODEL MS-1

Manufacturer

HOME WELLNESS WEST

Date Cleared

2000-04-04

(125 days)

Product Code

Regulation Number

Why did this record match?

Applicant Name (Manufacturer) :

HOME WELLNESS WEST

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty

Intended Use

THE INDICATIONS FOR USE OF THIS POWERED MUSCLE STIMULATOR FOR WHICH A DETERMINATION OF SUBSTANTIAL EQUIVALENCE IS SOUGHT ARE AS FOLLOWS: - Relaxation of muscle spasms - Prevention of retardation of disuse atrophy - Increasing local blood circulation - Muscle re-education - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Maintaining or increasing range of motion

Device Description

POWERED MUSCLE STIMULATOR

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