AccessGUDID - DEVICE: MES 9000 Dynamic EMG (D792N9200A0)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: D792N9200A0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053824652 *Terms of Use

Device Description: The Dynamic SEMG module of the MES 9000 allows for the recording of up to 8 channels of SEMG simultaneously. The MES 9000 offers you the flexibility to monitor and record the data in its raw state or as integrated data. The powerful and user-friendly software simplifies the recording of multiple muscle groups of antagonist and synergist muscles to facilitate assessment and case documentation. In addition, the system includes pre-programmed protocols and analysis for assessment, muscle education and relaxation training. The clinician may also program custom protocols - quickly and simply.

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
KZM	Device, Muscle Monitoring
HCC	Device, Biofeedback
IKN	Electromyograph, Diagnostic

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: 26f6028c-cd2a-483b-8c14-d03d7d115ea5
Public Version Date: June 08, 2021
Public Version Number: 4
DI Record Publish Date: February 11, 2017