AccessGUDID - DEVICE: MES 9000 Muscle Tester (D792N9600A0)

GUDID

Device Identifier (DI) Information

Brand Name: MES 9000 Muscle Tester
Version or Model: Muscle Tester
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MYOTRONICS NOROMED, INC

Primary DI Number: D792N9600A0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053824652 *Terms of Use

Device Description: Noromed computerized manual muscle testing offers manual muscle testing at its best by bringing science to what once was an art. The muscle testing hardware includes an ergonomic force gauge and five attachments to choose from which provide easy, comfortable testing of all muscle groups - large and small. Now you can perform real time strength testing - quickly and easily - and all fully documented by the computer interface. The flexibility of the system allows you to use pre-programmed established protocols or create your own. Designed to meet your needs, the software calculates the statistics appropriate to each test as well as generating a wide variety of documentation to fit your specific needs. This documentation includes: Supportive documentation reports which contain the graphic reports and profiles of the actual test data. Reports included are: •A composite report of individual test results by protocol and muscles tested as well as calculated deficits. •A test comparison report which collects and displays the patient's historical results. •A Myotest data report which presents both statistical data and graphical data of the individual test broken down by trial.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60925	Virtual-display rehabilitation system, non-supportive, clinical	An assembly of devices intended to be used in a clinical setting to provide non-gravity-compensating rehabilitation therapy for neuromuscular/musculoskeletal conditions affecting the back/trunk/limbs (e.g., impaired limb function) through patient interaction with a videogame-like display prompting repeated motion of a body part (e.g., arm, hand, leg) for functional improvement; it may also provide performance feedback. It does not provide weight support and is based on motion-sensing devices [e.g., battery-powered patient-worn infrared (IR) glove, motion tracking heel pad, movement tracking camera, software] that communicate wirelessly to provide a virtual-display interface.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HCC	Device, Biofeedback
KZM	Device, Muscle Monitoring

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K013399	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8cf90e98-f089-42ef-8e0e-0f6df10cbef3
Public Version Date: June 08, 2021
Public Version Number: 4
DI Record Publish Date: September 19, 2016