ErgoSpa

GUDID 00850020142033

PIVOTAL HEALTH SOLUTIONS, INC.

Examination/treatment table, line-powered Examination/treatment table, line-powered Examination/treatment table, line-powered Examination/treatment table, line-powered Examination/treatment table, line-powered Examination/treatment table, line-powered Examination/treatment table, line-powered Examination/treatment table, line-powered Examination/treatment table, line-powered Examination/treatment table, line-powered Examination/treatment table, line-powered Examination/treatment table, line-powered

• Primary Device ID: 00850020142033
• NIH Device Record Key: ac234150-1b18-4361-8a1e-b1beaf6fc718
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ErgoSpa
• Version Model Number: EGSPT
• 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	00850020142033 [Primary]

FDA Product Code

• INQ: Table, 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: 2021-09-29
• Device Publish Date: 2021-09-21

Devices Manufactured by PIVOTAL HEALTH SOLUTIONS, INC.

• 00850020142415 - Quantum Intersegmental Table: 2023-08-29
• 00850020142422 - Quantum Intersegmental Table, with Patient Assist: 2023-08-29
• 00854798000007 - Pelvic Health Table: 2023-08-29
• 00854798000038 - Essential Pelvic Health Table: 2023-08-29
• 00854798000045 - Tradeflex Max: 2023-08-29
• 00854798000052 - Tradeflex Max, Elevating: 2023-08-29
• 00850020142378 - Decompression of Choice: 2022-08-19
• 00850020142385 - Decompression of Choice: 2022-08-19