Parallel Bars Electric Platform Mount

GUDID 00854798000335

PIVOTAL HEALTH SOLUTIONS, INC.

Parallel bar exerciser, powered

• Primary Device ID: 00854798000335
• NIH Device Record Key: 5db16d35-e8f2-4c1e-a9c7-f6e0be3c8f93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Parallel Bars Electric Platform Mount
• Version Model Number: EPB10080B
• 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	00854798000335 [Primary]

FDA Product Code

• IRR: Bars, Parallel, 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: 2025-05-19
• Device Publish Date: 2025-05-09

On-Brand Devices [Parallel Bars Electric Platform Mount]

• 00854798000373: EPB10012B
• 00854798000342: EPB10010B
• 00854798000335: EPB10080B
• 00854798000328: EPB10012
• 00854798000311: EPB10010
• 00854798000298: EPB10080