PMRU-S KIT

GUDID B25972000

Electrical diagnostic functional assessment, combining range of motion, functional capacity, and electromyography testing

EMERGE DIAGNOSTICS LLC

Electromyography telemetric monitoring system
Primary Device IDB25972000
NIH Device Record Keydc44d308-3794-4415-b2b1-6abcbdb4db13
Commercial Distribution StatusIn Commercial Distribution
Brand NamePMRU-S KIT
Version Model Number7200
Company DUNS078787134
Company NameEMERGE DIAGNOSTICS LLC
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB25972000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OALExercise Equipment, Powered, Emg-Triggered

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 Date2017-01-26

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.