Pivotal Health Solutions

• ITH — Physical Medicine2 devices

• Z-1250-2015 — 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.Class II·Terminated·2014-12-17

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

• K131983 — ITRAC CERVICAL TRACTION SYSTEMCode ITH·2014-09-10
• K101889 — DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICECode ITH·2010-08-27