Pulse Lower Body Recovery Package 40125

GUDID 00817369021009

Pulse Recovery Package - Lower Body Power Tall

NORMATEC INDUSTRIES LP

Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system
Primary Device ID00817369021009
NIH Device Record Key3f21e0f3-4cd6-4f9d-b38a-59e9c344764b
Commercial Distribution StatusIn Commercial Distribution
Brand NamePulse Lower Body Recovery Package
Version Model NumberPulse Recovery Package - Lower Body Power Tall
Catalog Number40125
Company DUNS111448069
Company NameNORMATEC INDUSTRIES LP
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 Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100817369021009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IRPMassager, Powered Inflatable Tube

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-13

On-Brand Devices [Pulse Lower Body Recovery Package]

00817369021009Pulse Recovery Package - Lower Body Power Tall
00817369020996Pulse Recovery Package - Lower Body Power Standard
00817369020989Pulse Recovery Package - Lower Body Power Short
00817369020972Pulse Recovery Package - Lower Body Short
00817369020965Pulse Recovery Package - Lower Body Tall
00817369020958Pulse Recovery Package - Lower Body Standard

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