Sys*Stim 228

Basic Information

• Brand Name: Sys*Stim 228
• Primary DI: 00816864020159
• Version / Model: ME 228
• Catalog Number: ME 228
• Company Name: METTLER ELECTRONICS CORP.
• Labeler DUNS: 008513913
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-15
• Public Version: 4
• Public Version Date: 2019-05-23
• Public Version Status: Update
• Public Device Record Key: e4762904-44a1-4edd-8385-d74fd6599767

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LIH	INTERFERENTIAL CURRENT THERAPY	Neurology	882.5890	2
IPF	Stimulator, muscle, powered	Physical Medicine	890.5850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816864020159	GS1

Customer Contacts

• Phone: [phone] ext. 319
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K964028	000

Device Sizes

Type	Value	Unit	Text
Weight	4.9	Pound
Device Size Text, specify			No

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 167 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: No