Pivotal Health Solutions Inc

FDA Filings

This page includes the latest FDA filings for Pivotal Health Solutions Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3007278668
• FEI Number: 3007278668
• Name: PIVOTAL HEALTH SOLUTIONS
• Owner & Operator: Pivotal Health Solutions, Inc.
• Contact Address: 3003 9th AvE SW ; Watertown SD 57201 US
• Official Correspondent:
  • Julee L Driver
  • x-800-7437738-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 3003 9th Ave. SW ; Watertown, SD 57201 US
• Establishment Type:
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device

• Registration Number: 3034535
• FEI Number: 3003365828
• Name: Pivotal Health Solutions
• Owner & Operator: Pivotal Health Solutions, Inc.
• Contact Address: 3003 9th AvE SW ; Watertown SD 57201 US
• Official Correspondent:
  • Julee L Driver
  • x-800-7437738-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 800 48th St. Suite B; Springfield, OR 97478 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 00854798000281 PIVOTAL HEALTH SOLUTIONS, INC.	THERA-PTX	2024-07-24
GUDID 00854798000274 PIVOTAL HEALTH SOLUTIONS, INC.	THERA-PTX	2024-07-24
GUDID 00854798000052 PIVOTAL HEALTH SOLUTIONS, INC.	Tradeflex Max, Elevating	2023-08-29
GUDID 00854798000045 PIVOTAL HEALTH SOLUTIONS, INC.	Tradeflex Max	2023-08-29
GUDID 00854798000038 PIVOTAL HEALTH SOLUTIONS, INC.	Essential Pelvic Health Table	2023-08-29
GUDID 00854798000007 PIVOTAL HEALTH SOLUTIONS, INC.	Pelvic Health Table	2023-08-29
GUDID 00850020142422 PIVOTAL HEALTH SOLUTIONS, INC.	Quantum Intersegmental Table, with Patient Assist	2023-08-29
GUDID 00850020142415 PIVOTAL HEALTH SOLUTIONS, INC.	Quantum Intersegmental Table	2023-08-29
GUDID 00850020142408 PIVOTAL HEALTH SOLUTIONS, INC.	Decompression of Choice	2022-08-19
GUDID 00850020142392 PIVOTAL HEALTH SOLUTIONS, INC.	Decompression of Choice	2022-08-19
GUDID 00850020142385 PIVOTAL HEALTH SOLUTIONS, INC.	Decompression of Choice	2022-08-19
GUDID 00850020142378 PIVOTAL HEALTH SOLUTIONS, INC.	Decompression of Choice	2022-08-19
GUDID 00850020142316 PIVOTAL HEALTH SOLUTIONS, INC.	ErgoTherapy	2021-09-29
GUDID 00850020142033 PIVOTAL HEALTH SOLUTIONS, INC.	ErgoSpa	2021-09-29
GUDID 00852753008990 PIVOTAL HEALTH SOLUTIONS, INC.	Roller Massage Table	2021-09-06
GUDID 00852753008983 PIVOTAL HEALTH SOLUTIONS, INC.	Roller Massage Table	2021-09-06
GUDID 00852753008976 PIVOTAL HEALTH SOLUTIONS, INC.	Roller Massage Table	2021-09-06
GUDID 00850020142361 PIVOTAL HEALTH SOLUTIONS, INC.	Essential Thera-P	2021-09-06
GUDID 00850020142354 PIVOTAL HEALTH SOLUTIONS, INC.	Essential Thera-P	2021-09-06
GUDID 00850020142347 PIVOTAL HEALTH SOLUTIONS, INC.	Essential Thera-P	2021-09-06
GUDID 00850020142330 PIVOTAL HEALTH SOLUTIONS, INC.	Essential Thera-P	2021-09-06
GUDID 00850020142323 PIVOTAL HEALTH SOLUTIONS, INC.	Thera-P Elevating Tilt Table	2021-09-06
GUDID 00850020142309 PIVOTAL HEALTH SOLUTIONS, INC.	Thera-P Traction Table	2021-09-06
GUDID 00850020142293 PIVOTAL HEALTH SOLUTIONS, INC.	Thera-P	2021-09-06
GUDID 00850020142286 PIVOTAL HEALTH SOLUTIONS, INC.	Thera-P	2021-09-06
GUDID 00850020142279 PIVOTAL HEALTH SOLUTIONS, INC.	Treatment Table	2021-09-06
GUDID 00850020142262 PIVOTAL HEALTH SOLUTIONS, INC.	Treatment Table	2021-09-06
GUDID 00850020142255 PIVOTAL HEALTH SOLUTIONS, INC.	Treatment Table	2021-09-06
GUDID 00850020142248 PIVOTAL HEALTH SOLUTIONS, INC.	Treatment Table	2021-09-06
GUDID 00850020142231 PIVOTAL HEALTH SOLUTIONS, INC.	Treatment Table	2021-09-06
GUDID 00850020142224 PIVOTAL HEALTH SOLUTIONS, INC.	Electric Treatment Table	2021-09-06
GUDID 00850020142217 PIVOTAL HEALTH SOLUTIONS, INC.	Electric Treatment Table	2021-09-06
GUDID 00850020142200 PIVOTAL HEALTH SOLUTIONS, INC.	Electric Treatment Table	2021-09-06
GUDID 00850020142194 PIVOTAL HEALTH SOLUTIONS, INC.	Electric Treatment Table	2021-09-06
GUDID 00850020142187 PIVOTAL HEALTH SOLUTIONS, INC.	Electric Treatment Table	2021-09-06
GUDID 00850020142170 PIVOTAL HEALTH SOLUTIONS, INC.	Ergostyle HYLO	2021-09-06
GUDID 00850020142163 PIVOTAL HEALTH SOLUTIONS, INC.	Ergostyle HYLO	2021-09-06
GUDID 00850020142156 PIVOTAL HEALTH SOLUTIONS, INC.	Ergostyle HYLO	2021-09-06
GUDID 00850020142149 PIVOTAL HEALTH SOLUTIONS, INC.	Ergostyle HYLO	2021-09-06
GUDID 00850020142132 PIVOTAL HEALTH SOLUTIONS, INC.	Ergostyle HYLO	2021-09-06
GUDID 00850020142125 PIVOTAL HEALTH SOLUTIONS, INC.	Ergostyle HYLO	2021-09-06
GUDID 00850020142118 PIVOTAL HEALTH SOLUTIONS, INC.	Ergostyle HYLO	2021-09-06
GUDID 00850020142101 PIVOTAL HEALTH SOLUTIONS, INC.	Ergostyle HYLO	2021-09-06
GUDID 00850020142095 PIVOTAL HEALTH SOLUTIONS, INC.	HYLO IAT Elevating Table	2021-09-06
GUDID 00850020142088 PIVOTAL HEALTH SOLUTIONS, INC.	The Bolt - ME2002 Elevating Table	2021-09-06
GUDID 00850020142071 PIVOTAL HEALTH SOLUTIONS, INC.	Bariatric Exam Table	2021-09-06
GUDID 00850020142064 PIVOTAL HEALTH SOLUTIONS, INC.	Exam Table	2021-09-06
GUDID 00850020142057 PIVOTAL HEALTH SOLUTIONS, INC.	Bariatric Hi-Lo Mat Table	2021-09-06
GUDID 00850020142040 PIVOTAL HEALTH SOLUTIONS, INC.	Bariatric Hi-Lo Mat Table	2021-09-06
GUDID 00850020142026 PIVOTAL HEALTH SOLUTIONS, INC.	LAST Table	2021-09-06
GUDID 00850020142019 PIVOTAL HEALTH SOLUTIONS, INC.	LAST Table	2021-09-06
GUDID 00850020142002 PIVOTAL HEALTH SOLUTIONS, INC.	Thera-P	2021-09-06
GUDID 00850008449994 PIVOTAL HEALTH SOLUTIONS, INC.	Thera-P	2021-09-06
GUDID 00850008449987 PIVOTAL HEALTH SOLUTIONS, INC.	Thera-P	2021-09-06
GUDID 00850008449970 PIVOTAL HEALTH SOLUTIONS, INC.	Thera-P	2021-09-06
GUDID 00850008449963 PIVOTAL HEALTH SOLUTIONS, INC.	Essential Thera-P	2021-09-06
GUDID 00850008449956 PIVOTAL HEALTH SOLUTIONS, INC.	Essential Thera-P	2021-09-06
GUDID 00850008449949 PIVOTAL HEALTH SOLUTIONS, INC.	Ergowave Roller Massage Table	2021-09-06
GUDID 00850008449932 PIVOTAL HEALTH SOLUTIONS, INC.	Ergowave Roller Massage Table	2021-09-06
GUDID 00850008449925 PIVOTAL HEALTH SOLUTIONS, INC.	Tradeflex Flexion Table	2021-09-06
GUDID 00850008449918 PIVOTAL HEALTH SOLUTIONS, INC.	Tradeflex Flexion Table	2021-09-06
GUDID 00850008449901 PIVOTAL HEALTH SOLUTIONS, INC.	Tradeflex Flexion Table	2021-09-06
GUDID 00850008449895 PIVOTAL HEALTH SOLUTIONS, INC.	Tradeflex Flexion Table	2021-09-06
GUDID 00850008449888 PIVOTAL HEALTH SOLUTIONS, INC.	Tradeflex Flexion Table	2021-09-06
GUDID 00850008449871 PIVOTAL HEALTH SOLUTIONS, INC.	Tradeflex Flexion Table	2021-09-06
GUDID 00850008449864 PIVOTAL HEALTH SOLUTIONS, INC.	Tradeflex Flexion Table	2021-09-06
GUDID 00850008449857 PIVOTAL HEALTH SOLUTIONS, INC.	Tradeflex Flexion Table	2021-09-06
GUDID 00850008449840 PIVOTAL HEALTH SOLUTIONS, INC.	Trademark Elevating Table	2021-09-06
GUDID 00850008449833 PIVOTAL HEALTH SOLUTIONS, INC.	Trademark Stationary Table	2021-09-06
GUDID 00850008449826 PIVOTAL HEALTH SOLUTIONS, INC.	Trademark Elevating Table	2021-09-06
GUDID 00850008449819 PIVOTAL HEALTH SOLUTIONS, INC.	Trademark Stationary Table	2021-09-06
GUDID 00850008449802 PIVOTAL HEALTH SOLUTIONS, INC.	Ergostyle ES2000	2021-09-06
GUDID 00850008449796 PIVOTAL HEALTH SOLUTIONS, INC.	Ergostyle ES2000	2021-09-06
GUDID 00850008449789 PIVOTAL HEALTH SOLUTIONS, INC.	Ergostyle ES2000	2021-09-06
GUDID 00850008449772 PIVOTAL HEALTH SOLUTIONS, INC.	Ergostyle ES2000	2021-09-06
GUDID 00850008449765 PIVOTAL HEALTH SOLUTIONS, INC.	Ergostyle FX	2021-09-06
GUDID 00850008449758 PIVOTAL HEALTH SOLUTIONS, INC.	Ergostyle FX	2021-09-06
GUDID 00850008449741 PIVOTAL HEALTH SOLUTIONS, INC.	Ergostyle FX	2021-09-06
GUDID 00850008449734 PIVOTAL HEALTH SOLUTIONS, INC.	Ergostyle FX	2021-09-06
GUDID 00850008449727 PIVOTAL HEALTH SOLUTIONS, INC.	Ergostyle FX	2021-09-06
GUDID 00850008449710 PIVOTAL HEALTH SOLUTIONS, INC.	Ergostyle FX	2021-09-06
GUDID 00850008449703 PIVOTAL HEALTH SOLUTIONS, INC.	MAX Adjustment Table	2021-09-06
GUDID 00850008449697 PIVOTAL HEALTH SOLUTIONS, INC.	Tradebasic Adjustment Table	2021-09-06
GUDID 00850008449680 PIVOTAL HEALTH SOLUTIONS, INC.	Ergobasic Adjustment Table	2021-09-06
GUDID 00850008449673 PIVOTAL HEALTH SOLUTIONS, INC.	Ergobasic Adjustment Table	2021-09-06
GUDID 00850008449666 PIVOTAL HEALTH SOLUTIONS, INC.	Ergobasiic Adjustment Table	2021-09-06
GUDID 00850008449659 PIVOTAL HEALTH SOLUTIONS, INC.	EB Portable Chiropractic Table	2021-09-06
GUDID 00850008449642 PIVOTAL HEALTH SOLUTIONS, INC.	Ergobench Adjustment Table	2021-09-06
GUDID 00850008449635 PIVOTAL HEALTH SOLUTIONS, INC.	Ergobench Adjustment Table	2021-09-06
GUDID 00850008449628 PIVOTAL HEALTH SOLUTIONS, INC.	Ergobench Adjustable Table	2021-09-06
GUDID 00850008449611 PIVOTAL HEALTH SOLUTIONS, INC.	Ergobench Adjustment Table	2021-09-06
GUDID 00850008449604 PIVOTAL HEALTH SOLUTIONS, INC.	Ergobench Adjustment Table	2021-09-06
GUDID 00850008449598 PIVOTAL HEALTH SOLUTIONS, INC.	Ergobench Adjustment Table	2021-09-06
GUDID 00850008449581 PIVOTAL HEALTH SOLUTIONS, INC.	Electric Epidural Positioning Device	2021-09-06
GUDID 00850008449574 PIVOTAL HEALTH SOLUTIONS, INC.	Electric Epidural Positioning Device	2021-09-06
GUDID 00850008449550 PIVOTAL HEALTH SOLUTIONS, INC.	Epidural Positioning Device	2021-09-06
ION PIVOTAL HEALTH SOLUTIONS [Pivotal Health Solutions, Inc.]	Pass through Staircase	2019-06-27
GUDID 00852753008884 PIVOTAL HEALTH SOLUTIONS, INC.	Apollo	2019-05-07
GUDID 00852753008969 PIVOTAL HEALTH SOLUTIONS, INC.	Apollo	2019-01-08
GUDID 00852753008891 PIVOTAL HEALTH SOLUTIONS, INC.	Apollo	2019-01-08
GUDID 00852753008907 PIVOTAL HEALTH SOLUTIONS, INC.	Decompression of Choice	2018-11-16

Related Finance Registrations

NCAGE Code	603S1	PIVOTAL HEALTH SOLUTIONS, INC.
CAGE Code	603S1	PIVOTAL HEALTH SOLUTIONS, INC.
DUNS	826316098	PIVOTAL HEALTH SOLUTIONS, INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020081062124	Shanghai ,China (Mainland) -> Seattle, Washington	PORTABLE MASSAGE TABLE	807 PKG
2020061128611	Ningpo ,China (Mainland) -> Tacoma, Washington	AC MOTOR MOTOR PARTS THIS SHIPMENT CONTAINS NO WOOD PACKAGING MATERIALS	73 CTN
2020060121538	Shanghai ,China (Mainland) -> Portland, Oregon	PORTABLE MASSAGE TABLE	661 PKG
2020040730607	Shanghai ,China (Mainland) -> Portland, Oregon	PORTABLE MASSAGE TABLE	1091 PKG
2020012039336	Shanghai ,China (Mainland) -> Seattle, Washington	PORTABLE MASSAGE TABLE	637 CTN
2019122335595	Shanghai ,China (Mainland) -> Seattle, Washington	PORTABLE MASSAGE TABLE	600 PKG
2019111863824	Shanghai ,China (Mainland) -> Seattle, Washington	PORTABLE MASSAGE TABLE	790 PKG