RENPHO Air Compression Leg Massager

GUDID 10810140061208

Joicom Corporation

Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable

• Primary Device ID: 10810140061208
• NIH Device Record Key: ed582253-b29e-4e33-9b98-5464608a3752
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RENPHO Air Compression Leg Massager
• Version Model Number: RP-ALM071C
• 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	00810140061201 [Primary]
GS1	10810140061208 [Package]; Contains: 00810140061201; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222991

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: 2023-08-30
• Device Publish Date: 2023-08-22

Devices Manufactured by Joicom Corporation

• 10810140061000 - RENPHO Heating Pad: 2023-12-18
• 10810140061017 - RENPHO Heating Pad: 2023-12-18
• 10810140061024 - RENPHO Heating Pad: 2023-12-18
• 10810140061031 - RENPHO Heating Pad: 2023-12-18
• 10810140061048 - RENPHO Heating Pad: 2023-12-18
• 10810140061055 - RENPHO Heating Pad: 2023-12-18
• 10810140061062 - RENPHO Heating Pad: 2023-12-18
• 10810140061079 - RENPHO Heating Pad: 2023-12-18