RENPHO Air Compression Leg Massager

Basic Information

• Brand Name: RENPHO Air Compression Leg Massager
• Primary DI: 00810140061201
• Version / Model: RP-ALM071C
• Company Name: Joicom Corporation
• Labeler DUNS: 033774836
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-22
• Public Version: 1
• Public Version Date: 2023-08-30
• Public Version Status: New
• Public Device Record Key: ed582253-b29e-4e33-9b98-5464608a3752

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: 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
IRP	Massager, Powered Inflatable Tube	Physical Medicine	890.5650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44768	Multi-chamber venous compression system garment, reusable	An inflatable device in the form of a stocking, sleeve, or suit that is applied to the limbs externally to promote venous blood flow. As part of a compression system, the device applies pressure to the extremities through the sequential inflation of several chambers. The resulting increased venous blood flow may help to treat/prevent oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE) in non-ambulatory patients or patients at risk. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10810140061208	GS1		10	In Commercial Distribution
Primary	00810140061201	GS1

Premarket Submissions

Submission Number	Supplement Number
K222991	000