RENPHO Leg Massager

GUDID 10810140061178

Joicom Corporation

Multi-chamber venous compression system garment, reusable

• Primary Device ID: 10810140061178
• NIH Device Record Key: 3e46ab3d-502f-4d66-bf1b-474a66c68f0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RENPHO Leg Massager
• Version Model Number: R-F001
• Company DUNS: 033774836
• Company Name: Joicom Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810140061171 [Primary]
GS1	10810140061178 [Package]; Contains: 00810140061171; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222924

FDA Product Code

• IRP: Massager, Powered Inflatable Tube

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-14
• Device Publish Date: 2023-08-04

On-Brand Devices [RENPHO Leg Massager]

• 10850023727074: RP-ALM071H
• 10850023727050: RF-ALM070
• 10850023727043: RP-ALM070H
• 10850023727036: RF-ALM071
• 10810140061178: R-F001