4 results
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47ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Apollo (cold) Laser Desktop Control Units, Model AP2-DT. The Apollo IR Heat Lamp System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and / or promoting relaxation of muscle.
FDA Enforcement
Class II
·Terminated·Pivotal Health Solutions·March 18, 2015
Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table
FDA Enforcement
Class II
·Ongoing·Pivotal Health Solutions, Inc.·December 3, 2025
Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with practitioner definable target treatment location, treatment pounds, and patterns of treatment.
FDA Enforcement
Class II
·Ongoing·Pivotal Health Solutions, Inc.·July 17, 2024
Quantum Intersegmental Table, Model/Catalog Number: AMQ400H; heated massage table
FDA Enforcement
Class II
·Ongoing·Pivotal Health Solutions, Inc.·December 3, 2025