AccessGUDID - DEVICE: MES 9000 Musculoskeletal System (D792N9000M0)

GUDID

Device Identifier (DI) Information

Brand Name: MES 9000 Musculoskeletal System
Version or Model: N9000M
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MYOTRONICS NOROMED, INC

Primary DI Number: D792N9000M0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053824652 *Terms of Use

Device Description: Now you can have all of these capabilities in one compact system. Surface EMG, range of motion and muscle testing – may be purchased separately or in any combination. The modular design of the MES 9000 allows you to purchase any combination of modules and expand as your practice grows. The MES 9000 --- the modular system that enables you to do a complete, integrated evaluation with objective documentation that supports your diagnosis.

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
KQX	Goniometer, Ac-Powered
HCC	Device, Biofeedback

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: 883bae0f-d596-417d-9dd1-e4dd109901d5
Public Version Date: June 08, 2021
Public Version Number: 4
DI Record Publish Date: September 19, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
D792N91500	1	D792N9000M0	In Commercial Distribution	With Static EMG
D792N92000	1	D792N9000M0	In Commercial Distribution	With Dynamic EMG
D792N9200S0	1	D792N9000M0	In Commercial Distribution	With Dynamic EMG