Ergowave Roller Massage Table

GUDID 00850008449932

PIVOTAL HEALTH SOLUTIONS, INC.

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• Primary Device ID: 00850008449932
• NIH Device Record Key: 5d0225ba-1c49-4ebd-9326-367b95be8f47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ergowave Roller Massage Table
• Version Model Number: EW9080
• Company DUNS: 826316098
• Company Name: PIVOTAL HEALTH SOLUTIONS, 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850008449932 [Primary]

FDA Product Code

• ISA: Massager, Therapeutic, Electric

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: 2021-09-06
• Device Publish Date: 2021-08-27

On-Brand Devices [Ergowave Roller Massage Table]

• 00850008449949: EW9090
• 00850008449932: EW9080