Question 1

What types of medical devices does Pivotal Health Solutions, Inc. primarily manufacture?

Accepted Answer

Pivotal Health Solutions, Inc. specializes in examination and treatment tables for medical and rehabilitation use. Their portfolio includes line-powered and manual examination/treatment tables, programmable powered traction systems, and head/neck procedure positioners. They also produce powered parallel bar exercisers and specialized tables like elevating tilt and changing tables, catering to clinical and therapeutic environments.

Question 2

Where is Pivotal Health Solutions, Inc. based, and how does that affect its regulatory standing?

Accepted Answer

Pivotal Health Solutions, Inc. is based in the United States. As a U.S.-based manufacturer, its devices are subject to FDA regulations, including classification under the FDA’s device classification system (Class I, Class II, or Class IIa). The company’s devices are also listed in the FDA’s Unique Device Identifier (UDI) system, ensuring traceability and compliance with U.S. regulatory requirements.

Question 3

Which regulatory databases list devices manufactured by Pivotal Health Solutions, Inc.?

Accepted Answer

Devices from Pivotal Health Solutions, Inc. are listed in two key regulatory databases: the EU’s eudamed system and the FDA’s Unique Device Identifier (UDI) system. These listings help ensure transparency and compliance with both European and U.S. regulatory frameworks, depending on the market where the devices are distributed.

Question 4

How are Pivotal Health Solutions, Inc.’s devices classified under regulatory standards?

Accepted Answer

Pivotal Health Solutions, Inc.’s devices are classified under three regulatory categories: Class I (generally low-risk devices), Class II (moderate-risk devices requiring special controls), and Class IIa (a subset of Class II with additional regulatory oversight). The classification depends on factors like the device’s intended use, potential risks, and design complexity, as determined by regulatory bodies like the FDA and EU authorities.

Question 5

Why might a healthcare provider look for Pivotal Health Solutions, Inc.’s devices in regulatory registries like eudamed or the FDA UDI system?

Accepted Answer

Healthcare providers may check regulatory registries like eudamed or the FDA UDI system to verify the legitimacy, compliance, and traceability of medical devices before purchasing. These databases confirm whether a device has been properly listed and authorized for use in specific markets, ensuring it meets necessary safety and performance standards. For Pivotal Health Solutions, Inc., this visibility helps providers trust the device’s regulatory standing before integration into clinical or rehabilitation settings.

Device	Model / Reference	Registries	Class	Status
Tradeflex Flexion Table	E9217-L	FDA UDI	Class I	Active
Trademark Stationary Table	E9012	FDA UDI	Class I	Active
Tradeflex Flexion Table	E9017	FDA UDI	Class I	Active
Ergowave Roller Massage Table	EW9080	FDA UDI	Class I	Active
Tradeflex Flexion Table	E9218	FDA UDI	Class I	Active
Exam Table	ME2000	FDA UDI	Class I	Active
Decompression of Choice	E9022	FDA UDI	Class II	Active
Thera-P Elevating Tilt Table	HY1000	FDA UDI	Class I	Active
Ergostyle ES2000	ES9320	FDA UDI	Class I	Active
Elevating Changing Table	A4327-3052ELADA	FDA UDI	Class I	Active
Ergostyle ES2000	ES9300	FDA UDI	Class I	Active
Ergostyle HYLO	EH9400	FDA UDI	Class I	Active
AE Elevating Treatment Table	A4201-EL	FDA UDI	Class I	Active
Ergostyle HYLO	EH9530	FDA UDI	Class I	Active
Tradeflex Max, Elevating	E9118-L	FDA UDI	Class I	Active
Essential Thera-P	EPT9024	FDA UDI	Class I	Active
Essential Thera-P	EPT9020	FDA UDI	Class I	Active
Decompression of Choice	E9014-e	FDA UDI	Class II	Active
Trademark Stationary Table	E9212	FDA UDI	Class I	Active
Electric Epidural Positioning Device	EEPD220V	FDA UDI	Class I	Active
Parallel Bars Electric Platform Mount	EPB10012B	FDA UDI	Class I	Active
Eb8000	EB8000	EUDAMEDFDA UDI	Class I	Active
Decompression Table	E9014	EUDAMEDFDA UDI	Class IIa	Active
Ergobasic	EB9060	EUDAMEDFDA UDI	Class I	Active
Leg and Shoulder Table (LAST)	PT9069	EUDAMEDFDA UDI	Class I	Active
Ergostyle FX	ES5821	EUDAMEDFDA UDI	Class I	Active
Ergostyle ES2000	ES9310	EUDAMEDFDA UDI	Class I	Active
TheraP Electric Treatment Table	PT9029	EUDAMEDFDA UDI	Class I	Active
Bariatric TheraP Electric Treatment Table	PT9025	EUDAMEDFDA UDI	Class I	Active
Ergostyle ES2000	ES9330	EUDAMEDFDA UDI	Class I	Active
Essential Thera-P Electric Treatment Table	EPT9025	EUDAMEDFDA UDI	Class I	Active
ErgoBench	EB9020	EUDAMEDFDA UDI	Class I	Active
Traction Table	TXT	EUDAMEDFDA UDI	Class I	Active
Essential Thera-P Electric Treatment Table	EPT9021	EUDAMEDFDA UDI	Class I	Active
TOWER DOC Decompression Table	E9015	EUDAMEDFDA UDI	Class IIa	Active
Essential Thera-P Electric Treatment Table	EPT9029	EUDAMEDFDA UDI	Class I	Active
Ergostyle FX	ES5825	EUDAMEDFDA UDI	Class I	Active
ErgoBench	EB9010	EUDAMEDFDA UDI	Class I	Active
TheraP Electric Treatment Table	PT9021	EUDAMEDFDA UDI	Class I	Active

PIVOTAL HEALTH SOLUTIONS, INC.

What PIVOTAL HEALTH SOLUTIONS, INC. makes

Frequently asked questions

Information

Catalogue (39)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities