Catalog Number

-

Brand Name

SpineMED S200U Ultra Decompression System

Version/Model Number

S200U

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

Labeling does not contain MRI Safety Information

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

K051013

Product Code

ITH

Product Code Name

Equipment, Traction, Powered

Public Device Record Key

042238f2-f25b-4313-96ab-cc93d3d75d01

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 07, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-