RebaPad 002-60-0101

GUDID 00852318007604

Biofeedback System

ONDAMED INC.

Biofeedback system

• Primary Device ID: 00852318007604
• NIH Device Record Key: e4a45627-f06c-4838-b6cf-1a868912dfe7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RebaPad
• Version Model Number: 002-60-0101
• Catalog Number: 002-60-0101
• Company DUNS: 841720167
• Company Name: ONDAMED 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8455340456
• Email: support@ondamed.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852318007604 [Primary]

FDA Product Code

• HCC: Device, Biofeedback

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: 2017-08-23

Devices Manufactured by ONDAMED INC.

• 00852318007000 - ONDAMED: 2018-03-29 ONDAMED Main Unit
• 00852318007017 - ONDAMED: 2018-03-29 ONDAMED Hand Applicator
• 00852318007024 - ONDAMED: 2018-03-29 ONDAMED Neck Applicator
• 00852318007031 - ONDAMED: 2018-03-29 ONDAMED MA4 Applicator
• 00852318007048 - ONDAMED: 2018-03-29 ONDAMED MA8 Applicator
• 00852318007055 - ONDAMED: 2018-03-29 ONDAMED Regulator
• 00852318007215 - ONDAMED: 2018-03-29 ONDAMED Flex Applicator
• 00852318007505 - ONDAMED: 2018-03-29 ONDAMED Biofeedback System with MA4 and MA8