Data / Medical devices / United States / Pivotal Health Solutions

Pivotal Health Solutions: FDA-registered device maker in Watertown, SD, United States, 3 510(k) clearances

Name: Pivotal Health Solutions FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Pivotal Health Solutions is registered with the FDA (registration 3007278668) in Watertown, SD, United States. It lists 13 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 10, 2014. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Pivotal Health Solutions

FDA registration number: 3007278668
Address: 3003 9th Ave. SW, Watertown, SD, United States, 57201
Owner or operator: Pivotal Health Solutions, Inc. (10030456)
Roles: Complaint file establishment, Manufacturer
First device listed: October 6, 2009
Registered through: 2026
Brand names listed: Electric Parallel Bars, Parallel bars, Portable Parallel Bars

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Traction	ILZ	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Bars, Parallel, Exercise	IOE	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Bars, Parallel, Powered	IRR	1	Manufacturer	accessdata.fda.gov
Chair And Table, Medical	KMN	1	Manufacturer	accessdata.fda.gov
Equipment, Traction, Powered	ITH	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Exerciser, Non-Measuring	ION	1	Manufacturer	accessdata.fda.gov
Head Halter, Traction	IRS	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Lamp, Infrared, Therapeutic Heating	ILY	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Operating Room Accessories Table Tray	FWZ	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Table, Mechanical	INW	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Table, Operating-Room, Electrical	GDC	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Table, Powered	INQ	1	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 10, 2014	K131983	ITRAC CERVICAL TRACTION SYSTEM	ITH	Substantially Equivalent	Pivotal Health Solutions	accessdata.fda.gov
August 27, 2010	K101889	DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE	ITH	Substantially Equivalent	Pivotal Health Solutions	accessdata.fda.gov
March 21, 2006	K060134	APOLLO IR HEAT LAMP SYSTEM	ILY	Substantially Equivalent	Apollo Physical Therapy Products International	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
October 9, 2025	97861	Class II	Ongoing	Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table	The heat function may become damaged over time due to patients pressing on the areas with heat function components. Damage to components can lead to overheating which can lead to smoldering and melting of the vinyl cushion.	accessdata.fda.gov
April 29, 2024	94815	Class II	Ongoing	Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with practitioner definable target treatment location, treatment pounds, and patterns of treatment.	This product is being recalled due to potentially insufficient rework on a part (E7130-B) on the lumbar section of the frame on 6 distributed tables. There were 4 additional tables with the faulty E7130-B part that were manufactured, but had not been distributed yet.	accessdata.fda.gov
December 17, 2014	70473	Class II	Terminated	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 t	Control units were equipped with an internal mounting kit that does not meet medical safety standards, and are conductive, increasing the risk of electric shock to the user and patient. These units were manufactured prior to Pivotal Health Solutions acquisition of the Apollo product line.	accessdata.fda.gov

Compare with other makers

Updated November 24, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.