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Pivotal Health Solutions

United States·US-MF-000042753

Last updated September 17, 2026

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From the manufacturer's own website. Source

What Pivotal Health Solutions makes

Pivotal Health Solutions makes examination and treatment tables (both line-powered and manual), traction tables (line-powered and manual), parallel bar exercisers (powered), programmable powered traction systems, and musculoskeletal/physical therapy lasers (for home-use and professional use).

The company's devices are classified as Class I and Class II and are listed in Eudamed, FDA 510(k), and FDA UDI registries. Pivotal Health Solutions is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of devices does Pivotal Health Solutions manufacture?

Pivotal Health Solutions manufactures examination and treatment tables (both line-powered and manual), traction tables (line-powered and manual), parallel bar exercisers (powered), programmable powered traction systems, and musculoskeletal/physical therapy lasers (for home-use and professional use). These are the device categories explicitly listed in the provided data, and no other products or functions are attributed to the company in the source material.

Where is Pivotal Health Solutions based?

Pivotal Health Solutions is based in the United States, as stated directly in the SUMMARY section of the device data. The COUNTRY field confirms this as US, and no other location is mentioned or implied in the provided information.

In which regulatory registries are Pivotal Health Solutions' devices listed?

The devices manufactured by Pivotal Health Solutions are listed in Eudamed, FDA 510(k), and FDA UDI registries, as explicitly stated in the LISTED IN field and reiterated in the SUMMARY. These are the only registries named in the data, and no others are referenced or inferred.

How are Pivotal Health Solutions' devices classified under regulatory frameworks?

Pivotal Health Solutions' devices are classified as Class I and Class II, as specified in the DEVICE CLASSES field and confirmed in the SUMMARY. This classification indicates the level of regulatory control required, with Class I being low risk and Class II moderate risk, but the company itself is not approved or cleared—only individual devices may be authorized under these classes.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: 3003, 9th Avenue SW, Watertown, United States
Website: www.pivotalhealthsolutions.com/default.aspx
LinkedIn: —
Facebook: facebook.com/pivotalhealthsolutions
Email: [email protected]
Phone: —
PRRC Contact: Julee Driver
EUDAMED SRN: US-MF-000042753
FDA FEI Number: 3003365828
DUNS Number: —

Catalogue (83)

Page 2 of 2

Device	Model / Reference	Registries	Class	Status
Parallel Bars Electric Platform Mount	EPB10010	FDA UDI	Class I	Active
Pelvic Health Table	PT9045	FDA UDI	Class I	Active
Essential Thera-P	EPT9028	FDA UDI	Class I	Active
Changing Table	A4327-3052	FDA UDI	Class I	Active
The Bolt - ME2002 Elevating Table	ME2002	FDA UDI	Class I	Active
Ergostyle FX	ES5824	FDA UDI	Class I	Active
Thera-P	PT9024	FDA UDI	Class I	Active
Apollo	Handheld, HH	FDA UDI	Class II	Active
LAST Table	PT9060	FDA UDI	Class I	Active
Parallel Bars Electric Platform Mount	EPB10080	FDA UDI	Class I	Active
Roller Massage Table	IST-350	FDA UDI	Class I	Active
Ergostyle HYLO	EH9421	FDA UDI	Class I	Active
Tradeflex Flexion Table	E9217	FDA UDI	Class I	Active
ErgoSpa	EGSPT	FDA UDI	Class I	Active
Thera-Ptx	PTX-9041	FDA UDI	Class I	Active
Decompression Table	E9014	EUDAMEDFDA UDI	Class IIa	Active
Ergostyle Hylo	EH9540	EUDAMEDFDA UDI	Class I	Active
Ergostyle Hylo	EH9420	EUDAMEDFDA UDI	Class I	Active
Ergowave	EW9090	EUDAMEDFDA UDI	Class I	Active
Itrac Cervical Traction System	K131983	FDA 510(k)	Class II	Active
Decompression Of Choice And Neuro Decompression Device	K101889	FDA 510(k)	Class II	Active
Ergostyle ES2000	ES9310	EUDAMEDFDA UDI	Class I	Active
ErgoBench	EB9030	EUDAMEDFDA UDI	Class I	Active
Ergobasic	EB9040	EUDAMEDFDA UDI	Class I	Active
Ergostyle FX	ES5823	EUDAMEDFDA UDI	Class I	Active
ErgoBench	EB9000	EUDAMEDFDA UDI	Class I	Active
Ergobasic	EB9050	EUDAMEDFDA UDI	Class I	Active
ErgoBench	EB9020	EUDAMEDFDA UDI	Class I	Active
Ergostyle Hylo	EH9422	EUDAMEDFDA UDI	Class I	Active
Epidural Positioning Device (EPD Package 2)	EPD Package 2	EUDAMEDFDA UDI	Class I	Active
Eb8000	EB8020	EUDAMEDFDA UDI	Class I	Active
Ergobasic	EB9061	EUDAMEDFDA UDI	Class I	Active
Ergostyle Hylo	EH9520	EUDAMEDFDA UDI	Class I	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (4)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

There are 4 recall records for Pivotal Health Solutions, with the earliest initiated on 2014-12-17 and the most recent on 2025-10-09. The statuses of these recalls include open, classified, and terminated. The reasons given for the recalls are: potentially insufficient rework on part E7130-B on the lumbar section of the frame for 6 distributed tables (with 4 additional undistributed tables affected); control units equipped with an internal mounting kit that does not meet medical safety standards and is conductive, increasing the risk of electric shock; and the heat function becoming damaged over time due to patient pressure, which can lead to overheating, smoldering, and melting of the vinyl cushion.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Oct 9, 2025	Z-0587-2026	—	open, classified	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.
Oct 9, 2025	Z-0588-2026	—	open, classified	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.
Apr 29, 2024	Z-2326-2024	—	open, classified	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.
Dec 17, 2014	Z-1250-2015	—	terminated	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.