RS-4s Muscle Stimulator System - RS-4s Muscle Stimulator System. Kit includes - R S Medical

Duns Number:625133228

Device Description: RS-4s Muscle Stimulator System. Kit includes RS-4s Muscle Stimulator, treatment cable, rec RS-4s Muscle Stimulator System. Kit includes RS-4s Muscle Stimulator, treatment cable, rechargeable battery, battery charging dock, AC adapter, and treatment electrodes.

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More Product Details

Catalog Number

-

Brand Name

RS-4s Muscle Stimulator System

Version/Model Number

950-0062-00

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K112348

Product Code Details

Product Code

IPF

Product Code Name

Stimulator, Muscle, Powered

Device Record Status

Public Device Record Key

0335b8e4-6e08-484c-8238-3ad6cdf7e2ee

Public Version Date

September 22, 2022

Public Version Number

1

DI Record Publish Date

September 14, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"R S MEDICAL" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 15