RS-4i Plus Sequential Stimulator Kit (R) - RS-4i Plus Sequential Stimulator with - R S Medical

Duns Number:625133228

Device Description: RS-4i Plus Sequential Stimulator with Intersperse, Refurbished. Kit includes RS-4i Plus In RS-4i Plus Sequential Stimulator with Intersperse, Refurbished. Kit includes RS-4i Plus Interferential Stimulator, treatment cable, rechargeable battery, battery charging dock, AC adapter, and treatment electrodes.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

RS-4i Plus Sequential Stimulator Kit (R)

Version/Model Number

960-0100-00

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

7e3d6beb-4ec6-4c43-8da2-634d103578f0

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

March 04, 2020

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