EMST150

Basic Information

• Brand Name: EMST150
• Primary DI: 00793573085498
• Version / Model: 150
• Company Name: Aspire Products LLC
• Labeler DUNS: 805601585
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-01
• Public Version: 1
• Public Version Date: 2023-03-09
• Public Version Status: New
• Public Device Record Key: d72181af-d7ff-4261-a381-edeac0fdb2a6

Device Description

EMST150 expiratory muscle strength trainer (handheld exerciser ).The EMST150 is a calibrated muscle strength trainer designed specifically for individuals who want to increase the strength of their voice,cough and swallow muscles

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
ION	Exerciser, Non-Measuring	Physical Medicine	890.5370	1

GMDN Terms

Code	Name	Definition	Implantable	Status
14337	PEEP valve, reusable	A non-sterile device used in a respiratory or anaesthesia breathing circuit or system to maintain a selected level of positive end expiratory pressure (PEEP) in a patient's airway during ventilation. The device is typically constructed of plastic and metal materials, and has a valve(s) actuated with a spring(s) to provide the airway resistance, and an adjustable knob or dial (usually graduated) to adjust the resistance level typically between 5 to 20 cmH2O. It is used with ventilators, stand-alone breathing systems for oxygen delivery, pulmonary resuscitators, or anaesthetic breathing systems often having an expiratory valve function. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00793573085498	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]