ProSlate

GUDID B398PS080

ProSlate 8 Speech Generating Device

FORBES REHAB SERVICES INC

Voice synthesizer/digitizer

• Primary Device ID: B398PS080
• NIH Device Record Key: 5ac7c389-463c-4e31-b029-f966330096af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProSlate
• Version Model Number: ProSlate 8
• Company DUNS: 620089854
• Company Name: FORBES REHAB SERVICES 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 4195897688
• Email: support@forbesaac.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B398PS080 [Primary]

FDA Product Code

• ILQ: System, Communication, Powered

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: 2019-06-11
• Device Publish Date: 2019-06-03

On-Brand Devices [ProSlate]

• B398PS130: ProSlate 13 Speech Generating Device
• B398PS100: ProSlate Speech Generating Device
• B398PS080: ProSlate 8 Speech Generating Device
• B398PS040: ProSlate 4 Speech Generating Device
• B398PS060: ProSlate 6 Speech Generating Device