ReGrasp - ReGrasp Clinician System - Rehabtronics Inc

Duns Number:243936569

Device Description: ReGrasp Clinician System

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More Product Details

Catalog Number

-

Brand Name

ReGrasp

Version/Model Number

RHTHS1C

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

K153163

Product Code Details

Product Code

GZI

Product Code Name

Stimulator, Neuromuscular, External Functional

Device Record Status

Public Device Record Key

c369644c-44ab-4df0-8bd6-e37d6598548e

Public Version Date

February 19, 2021

Public Version Number

8

DI Record Publish Date

August 29, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"REHABTRONICS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 16