Smart Check Cushion Monitoring Device

Basic Information

• Brand Name: Smart Check Cushion Monitoring Device
• Primary DI: 00613732087746
• Version / Model: SMARTCHECK-01
• Company Name: Roho, Inc.
• Labeler DUNS: 006614792
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-25
• Public Version: 1
• Public Version Date: 2022-12-05
• Public Version Status: New
• Public Device Record Key: 62c7a999-aa1f-4cda-9ff2-6351c5b8effe

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
JFC	System, Pressure Measurement, Intermittent	Physical Medicine	890.1600	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46965	Wheelchair occupant position sensor	An electrically-powered device intended to be used with a wheelchair to provide the occupant with feedback on their seating position/placement. It is in the form of a flat, electronic pad placed on the seat of the wheelchair, or attached to a seat cushion, and which responds to physical stimuli. After the occupant establishes a sitting position, the device can signal unwanted movement from the position and/or indicate when the position has been prolonged sufficient to put the occupant at risk of pressure-associated complications; data may be transmitted to an off-the-shelf computing device for recording/display.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00613732087746	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -13 – 158 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 0 – 93 Percent (%) Relative Humidity