SaeboRejoyce K4-RJ-10---1

GUDID 00850331006567

Virtual-display arm rehabilitation system

SAEBO, INC.

Virtual-display arm rehabilitation system, non-gravity-compensating

• Primary Device ID: 00850331006567
• NIH Device Record Key: ad1da9fd-809c-43f7-8848-0f46071b9ff8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SaeboRejoyce
• Version Model Number: SaeboRejoyce
• Catalog Number: K4-RJ-10---1
• Company DUNS: 168569098
• Company Name: SAEBO, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true

Customer Support Contacts

• Phone: 888-284-5433
• Email: Info@saebo.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850331006567 [Primary]

FDA Product Code

• IKK: System, Isokinetic Testing And Evaluation

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-26

Devices Manufactured by SAEBO, INC.

• 00850331006949 - SaeboTrodes Electrodes: 2018-07-06 SaeboTrode Electrodes,Round 1.25", 1 pack, qty 4
• 00850331006956 - SaeboTrodes Electrodes: 2018-07-06 SaeboTrode Electrodes, Round, 2", 1 pack, Qty 4
• 00850331006963 - SaeboTrodes Electrodes: 2018-07-06 SaeboTrode Electrodes, Rectangular, 2" x 3.5", 1 pack, Qty 4
• 00850331006567 - SaeboRejoyce: 2018-03-29Virtual-display arm rehabilitation system
• 00850331006567 - SaeboRejoyce: 2018-03-29 Virtual-display arm rehabilitation system