RT300

GUDID FA217786

RESTORATIVE THERAPIES, INC.

Physical therapy transcutaneous electrical stimulation system, line-powered
Primary Device IDFA217786
NIH Device Record Keyf2fa7405-fc34-489d-805a-eaba92a7f533
Commercial Distribution StatusIn Commercial Distribution
Brand NameRT300
Version Model NumberRT300-SLA Supine
Company DUNS186976408
Company NameRESTORATIVE THERAPIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCFA217786 [Primary]

FDA Product Code

GZIStimulator, Neuromuscular, External Functional

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-05-23
Device Publish Date2016-09-16

On-Brand Devices [RT300]

FA218481RT300-SA Desktop
FA218039RT300-SA
FA217791RT300-LA supine
FA217787RT300-SLSA Supine
FA217786RT300-SLA Supine
FA216912SAGE stimulator
FA216769RT300-SLP
FA109080RT300-LSA
FA104581RT300-SLSA
FA102011RT300-SLA
FA100052RT300-SL

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