Catalog Number

-

Brand Name

Wearable Antenna Assembly/StimQ Wearable Antenna Gear

Version/Model Number

PDBT-915-2K

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K170141,K171366

Product Code

GZB

Product Code Name

Stimulator, Spinal-Cord, Implanted (Pain Relief)

Public Device Record Key

d42803dd-e439-45d4-bdd0-a4c365811b6d

Public Version Date

July 07, 2020

Public Version Number

5

DI Record Publish Date

February 05, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-