Catalog Number

N51-DM-11-2-022-01A-2

Brand Name

NUGABEST

Version/Model Number

N5-1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

September 07, 2025

Issuing Agency

In GS1

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

K153054

Product Code

JFB

Product Code Name

Table, Physical Therapy, Multi Function

Public Device Record Key

ed67a139-5a86-4491-b465-26bf5c82b64b

Public Version Date

October 06, 2022

Public Version Number

1

DI Record Publish Date

September 28, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-