Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007278668

FEI Number

3007278668

Entity Name

PIVOTAL HEALTH SOLUTIONS

City/State/Country

Watertown, SD, US

Establishment Address

3003 9th Ave. SW, Watertown, SD 57201, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Pivotal Health Solutions, Inc. (Owner Number: 10030456)

Owner / Operator Contact Address

3003 9th Ave SW, Watertown, SD 57201, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Parallel bars Portable Parallel Bars Electric Parallel Bars

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IOE	Bars, Parallel, Exercise	Physical Medicine	Class 1	890.5370	2021-08-26
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2011-01-11
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2020-09-14
INQ	Table, Powered	Physical Medicine	Class 1	890.3760	2009-10-06
IRR	Bars, Parallel, Powered	Physical Medicine	Class 1	890.5380	2024-12-17
GDC	Table, Operating-Room, Electrical	General, Plastic Surgery	Class 1	878.4960	2013-12-10
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2019-06-27

Official Correspondent

Julee Driver

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Pivotal Health Solutions, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3034535	Pivotal Health Solutions	Springfield, OR, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007278668. Last updated year: 2026. Please use registration number 3007278668 when referencing this establishment in official correspondence.