PMRU-S KIT

Primary DI
B25972000
Brand
PMRU-S KIT
Company
EMERGE DIAGNOSTICS LLC
Model
7200
Device description
Electrical diagnostic functional assessment, combining range of motion, functional capacity, and electromyography testing
Published
2017-01-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OALExercise Equipment, Powered, Emg-Triggered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OALExercise Equipment, Powered, Emg-TriggeredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123902000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123902000PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)Oktx, LLC2013-09-13IKN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B25972000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electromyography telemetric monitoring systemAn assembly of devices designed to continuously measure and wirelessly transmit electromyographic (EMG) signals from a patient to a receiving location (e.g., central station, bedside monitor) for viewing. It typically consists of a portable transmitter with antenna and attached sensors (e.g., leads and electrodes) that are connected to the patient, as well as a receiver typically incorporated into a central station or bedside monitor that receives, consolidates, and displays the information. The system is typically used for ambulatory patients who require continuous monitoring (e.g., patients in step-down care areas).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078787134
Device count
1
Serial number
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00855846007146MyoPro 2+Myomo, Inc.OAL2021-09-14
00855846007153MyoPro 2+Myomo, Inc.OAL2021-09-14
00855846007160MyoPro 2+Myomo, Inc.OAL2021-09-14
00855846007139MyoPro 2+Myomo, Inc.OAL2021-08-28
00855846007122Mobile Arm Rehabilitation Kit (MARK)Myomo, Inc.OAL2018-03-28
00855846007009MyoProMyomo, Inc.OAL2017-04-01
00855846007016MyoProMyomo, Inc.OAL2017-04-01
00855846007023MyoProMyomo, Inc.OAL2017-04-01
00855846007030MyoProMyomo, Inc.OAL2017-04-01
00855846007047MyoProMyomo, Inc.OAL2017-04-01
00855846007054MyoProMyomo, Inc.OAL2017-04-01
00855846007061MyoProMyomo, Inc.OAL2017-04-01
00855846007078MyoProMyomo, Inc.OAL2017-04-01
00855846007085MyoProMyomo, Inc.OAL2017-04-01
00855846007092MyoProMyomo, Inc.OAL2017-04-01
00855846007108MyoProMyomo, Inc.OAL2017-04-01
00855846007115MyoProMyomo, Inc.OAL2017-04-01