Rapid Reboot Recovery Products

GUDID B691SPREN1

REGEN Control Unit

RAPID REBOOT RECOVERY PRODUCTS LLC

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• Primary Device ID: B691SPREN1
• NIH Device Record Key: fc2ba98e-f6f3-42e9-87b7-2c1742c19f68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rapid Reboot Recovery Products
• Version Model Number: SP-REN-1
• Company DUNS: 080628101
• Company Name: RAPID REBOOT RECOVERY PRODUCTS LLC
• 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: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B691SPREN1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203552

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: 2021-07-20
• Device Publish Date: 2021-07-12

On-Brand Devices [Rapid Reboot Recovery Products]

• B691SPREN1: REGEN Control Unit
• B691SPREN031: RR REGEN Control Unit + Three Attachments
• B691SPREN021: RR REGEN Control Unit + Two Attachments
• B691SPREN011: RR REGEN Control Unit + Single Attachment
• B691SPGEN031: RR GENESIS Control Unit + Three Attachments
• B691SPGEN021: RR GENESIS Control Unit + Two Attachments
• B691SPGEN011: RR GENESIS Control Unit + Single Attachment
• B691SPCL031: RR CLASSIC Control Unit + Three Attachments
• B691SPCL021: RR CLASSIC Control Unit + Two Attachments
• B691SPCL011: RR CLASSIC Control Unit + Single Attachment