AccessGUDID - DEVICE: Sys*Stim 228 (00816864020159)

GUDID

Device Identifier (DI) Information

Brand Name: Sys*Stim 228
Version or Model: ME 228
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ME 228
Company Name: METTLER ELECTRONICS CORP.

Primary DI Number: 00816864020159
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008513913 *Terms of Use

Device Description: Neuromuscular stimulator features 4 discrete waveforms (advanced 2-channel, multifunction)

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
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?
46571	Physical therapy transcutaneous electrical stimulation system, line-powered	An assembly of mains electricity (AC-powered) devices used to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy. It typically includes an electric current pulse generator, electrodes/probes, audible and/or visual indicators, and software. It may provide biofeedback and/or transcutaneous electrical nerve stimulation (TENS) to treat pain. It is typically used to prevent muscle atrophy, for muscle re-education, to relax muscle spasms, to improve blood circulation, for postsurgical calf muscle stimulation to prevent venous thrombosis, and/or to maintain or increase range of motion.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LIH	INTERFERENTIAL CURRENT THERAPY
IPF	Stimulator, muscle, powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K964028	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
Storage Environment Temperature: between -40 and 167 Degrees Fahrenheit
Special Storage Condition, Specify: No

Clinically Relevant Size

[?]

Size Type Text
Weight: 4.9 Pound
Device Size Text, specify: No

Device Record Status

Public Device Record Key: e4762904-44a1-4edd-8385-d74fd6599767
Public Version Date: May 23, 2019
Public Version Number: 4
DI Record Publish Date: September 15, 2016