UNITE MEDICAL, LLC

Matched from indexed company URL: Unite Medical, LLC

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3015727296	3015727296	UNITE MEDICAL, LLC	1	Y	2026-01-01	1487 Trae Lane Lithia Springs GA US 30122

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00850012035312	Unite Medical® - The Unite Medical® Cryo Pneumatic Shoulder orthosis combines pneumatic compression with cold therapy in a universal design. Indicated for post-op application or as an adjuct to a physical therapy regime, the Cryo Pneumatic Shoulder orthosis offers a wide variety of treatment options. Aids in the reduction of swelling, reduced muscle spasms, and pain relief.	833-868-6483	info@unitemedical.net
00850012035619	Unite Medical® - The Unite Medical® heel stabilizer is designed with medical grade silicone combined with a soft gel center providing pain relief to the heel region. The heel stabilizer helps to reduce pain associated with Achilles tendinitis, plantar fasciitis, heel and calcaneal spurs as well as providing additional load & vibration relief for arthritis in the knee and leg joints.	833.868.6483	info@unitemedical.net

unitemedical.net

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
232173	2032995753	K222898	SafeSource Direct Blue Powder-Free Nitrile Exam Gloves	LZA	2022-11-07
232173	1710441155	K221134	Procedure Mask with Ear Loops and Surgical Mask with Ties	FXX	2022-05-19
232173	1700010384	K211762	Altor Safety 4-Ply Surgical Mask (Model:62232)	FXX	2021-09-03
232173	1589307212	K211249	Altor Safety 3-Ply Surgical Mask (Model:62222)	FXX	2021-07-23
232173	1075669952	K210200	1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock	FMF	2021-05-14
232173	1503506270	K202842	Medical surgical mask	FXX	2021-11-26
232173	1666854848	K201284	Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use, with needle, Sterile Hypodermic needle for Single use	FMF	2020-12-14
232173	1865142403	K200093	Synthetic Nitrile Patient Exam Gloves, Powder Free, Blue, Tested for Use w/Chemotherapy Drug	LZA	2020-08-20
232173	1633839506	K200019	Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black)	LZA	2020-04-06
232173	1840776095	K170136	Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs	LZA	2017-08-25
232173	1043489149
232173	1377574867
232173	1558709967
232173	1561449526
232173	1575366006
232173	1576571530
232173	1606951728
232173	1619012293
232173	1624773590
232173	1656926905
232173	1664268193
232173	1668877778
232173	1737163108
232173	1783478433
232173	1856312473
232173	1864186096
232173	1986154199

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
LZA	4	2022-11-07
FXX	4	2022-05-19
FMF	2	2021-05-14

GUDID#

RegeniCool™ Pro - RegeniCool™ Pro is a cold compression therapy system intended to provide localized cold therapy through circulating chilled water for the temporary reduction of pain and swelling following surgery or injury. The system consists of a portable base unit with an integrated reservoir and pump that circulates chilled water through a compatible therapy wrap applied to the treatment area. The device offers adjustable therapy settings that control water circulation timing and hydraulic pressure within the wrap. It is intended for use in clinical or home settings under the direction of a licensed healthcare provider. The device does not utilize pneumatic (air-driven) compression. Compatible wraps are packaged separately.

Unite Medical, LLC

2026-03-13

RegeniCool™ Pro - RegeniCool™ Pro is a cold compression therapy system intended to provide localized cold therapy through circulating chilled water for the temporary reduction of pain and swelling following surgery or injury. The system consists of a portable base unit with an integrated reservoir and pump that circulates chilled water through a compatible therapy wrap applied to the treatment area. The device offers adjustable therapy settings that control water circulation timing and hydraulic pressure within the wrap. It is intended for use in clinical or home settings under the direction of a licensed healthcare provider. The device does not utilize pneumatic (air-driven) compression. Compatible wraps are packaged separately.

Unite Medical, LLC

2026-03-13

Unite Medical® - The Unite Medical® Cryo Pneumatic Shoulder orthosis combines pneumatic compression with cold therapy in a universal design. Indicated for post-op application or as an adjuct to a physical therapy regime, the Cryo Pneumatic Shoulder orthosis offers a wide variety of treatment options. Aids in the reduction of swelling, reduced muscle spasms, and pain relief.

Unite Medical, LLC

2024-06-20

Unite Medical® - The Unite Medical® heel stabilizer is designed with medical grade silicone combined with a soft gel center providing pain relief to the heel region. The heel stabilizer helps to reduce pain associated with Achilles tendinitis, plantar fasciitis, heel and calcaneal spurs as well as providing additional load & vibration relief for arthritis in the knee and leg joints.

Unite Medical, LLC

2023-12-28

Unite Medical® - The Unite Medical® heel stabilizer is designed with medical grade silicone combined with a soft gel center providing pain relief to the heel region. The heel stabilizer helps to reduce pain associated with Achilles tendinitis, plantar fasciitis, heel and calcaneal spurs as well as providing additional load & vibration relief for arthritis in the knee and leg joints.

Unite Medical, LLC

2023-12-28

Unite Medical® - The Unite Medical® heel stabilizer is designed with medical grade silicone combined with a soft gel center providing pain relief to the heel region. The heel stabilizer helps to reduce pain associated with Achilles tendinitis, plantar fasciitis, heel and calcaneal spurs as well as providing additional load & vibration relief for arthritis in the knee and leg joints.

Unite Medical, LLC

2023-12-28

Unite Medical® - The Unite Medical® heel stabilizer is designed with medical grade silicone combined with a soft gel center providing pain relief to the heel region. The heel stabilizer helps to reduce pain associated with Achilles tendinitis, plantar fasciitis, heel and calcaneal spurs as well as providing additional load & vibration relief for arthritis in the knee and leg joints.

Unite Medical, LLC

2023-12-28

Unite Medical® - Introducing the Unite Medical® Tall Pneumatic Walking Boot, designed for superior support and comfort in treating soft tissue injuries, grade 2 and 3 sprains, stable fractures, and post-operative stabilization. This boot features an inflatable bladder for enhanced immobilization, a lightweight low rocker profile for greater comfort, and a cushioned heel for optimal energy absorption. Its versatile design fits either foot and promotes a natural gait pattern for improved mobility.

Unite Medical, LLC

2024-06-20

Unite Medical® - Introducing the Unite Medical® Tall Pneumatic Walking Boot, designed for superior support and comfort in treating soft tissue injuries, grade 2 and 3 sprains, stable fractures, and post-operative stabilization. This boot features an inflatable bladder for enhanced immobilization, a lightweight low rocker profile for greater comfort, and a cushioned heel for optimal energy absorption. Its versatile design fits either foot and promotes a natural gait pattern for improved mobility.

Unite Medical, LLC

2024-06-20

Unite Medical® - Introducing the Unite Medical® Tall Pneumatic Walking Boot, designed for superior support and comfort in treating soft tissue injuries, grade 2 and 3 sprains, stable fractures, and post-operative stabilization. This boot features an inflatable bladder for enhanced immobilization, a lightweight low rocker profile for greater comfort, and a cushioned heel for optimal energy absorption. Its versatile design fits either foot and promotes a natural gait pattern for improved mobility.

Unite Medical, LLC

2024-06-20

Unite Medical® - Introducing the Unite Medical® Tall Pneumatic Walking Boot, designed for superior support and comfort in treating soft tissue injuries, grade 2 and 3 sprains, stable fractures, and post-operative stabilization. This boot features an inflatable bladder for enhanced immobilization, a lightweight low rocker profile for greater comfort, and a cushioned heel for optimal energy absorption. Its versatile design fits either foot and promotes a natural gait pattern for improved mobility.

Unite Medical, LLC

2024-06-20

Unite Medical® - Introducing the Unite Medical® Tall Pneumatic Walking Boot, designed for superior support and comfort in treating soft tissue injuries, grade 2 and 3 sprains, stable fractures, and post-operative stabilization. This boot features an inflatable bladder for enhanced immobilization, a lightweight low rocker profile for greater comfort, and a cushioned heel for optimal energy absorption. Its versatile design fits either foot and promotes a natural gait pattern for improved mobility.

Unite Medical, LLC

2024-06-20

Unite Medical® - Introducing the Unite Medical® Short Pneumatic Walking Boot, designed for superior support and comfort in treating soft tissue injuries, grade 2 and 3 sprains, stable fractures, and post-operative stabilization. This boot features an inflatable bladder for enhanced immobilization, a lightweight low rocker profile for greater comfort, and a cushioned heel for optimal energy absorption. Its versatile design fits either foot and promotes a natural gait pattern for improved mobility.

Unite Medical, LLC

2024-06-20

Unite Medical® - Introducing the Unite Medical® Short Pneumatic Walking Boot, designed for superior support and comfort in treating soft tissue injuries, grade 2 and 3 sprains, stable fractures, and post-operative stabilization. This boot features an inflatable bladder for enhanced immobilization, a lightweight low rocker profile for greater comfort, and a cushioned heel for optimal energy absorption. Its versatile design fits either foot and promotes a natural gait pattern for improved mobility.

Unite Medical, LLC

2024-06-20

Unite Medical® - Introducing the Unite Medical® Short Pneumatic Walking Boot, designed for superior support and comfort in treating soft tissue injuries, grade 2 and 3 sprains, stable fractures, and post-operative stabilization. This boot features an inflatable bladder for enhanced immobilization, a lightweight low rocker profile for greater comfort, and a cushioned heel for optimal energy absorption. Its versatile design fits either foot and promotes a natural gait pattern for improved mobility.

Unite Medical, LLC

2024-06-20

Unite Medical® - Introducing the Unite Medical® Short Pneumatic Walking Boot, designed for superior support and comfort in treating soft tissue injuries, grade 2 and 3 sprains, stable fractures, and post-operative stabilization. This boot features an inflatable bladder for enhanced immobilization, a lightweight low rocker profile for greater comfort, and a cushioned heel for optimal energy absorption. Its versatile design fits either foot and promotes a natural gait pattern for improved mobility.

Unite Medical, LLC

2024-06-20

Unite Medical® - Introducing the Unite Medical® Short Pneumatic Walking Boot, designed for superior support and comfort in treating soft tissue injuries, grade 2 and 3 sprains, stable fractures, and post-operative stabilization. This boot features an inflatable bladder for enhanced immobilization, a lightweight low rocker profile for greater comfort, and a cushioned heel for optimal energy absorption. Its versatile design fits either foot and promotes a natural gait pattern for improved mobility.

Unite Medical, LLC

2024-06-20

Unite Medical® - The Unite Medical® Universal ROM Knee Brace is indicated for mild to moderate ligament joint pain, sprains, and strains of the knee ligaments. This lightweight brace design connects the needs of the serious athlete with the added benefit of Range of Motion (ROM). Removable hinges allow for easy adjustment.

Unite Medical, LLC

2023-12-28

Unite Medical® - The Unite Medical® Deluxe Universal ROM Knee Brace is indicated for mild to moderate ligament joint pain, sprains, and strains of the knee ligaments. This lightweight brace design connects the needs of the serious athlete with the added benefit of Range of Motion (ROM). Removable hinges allow for easy adjustment.

Unite Medical, LLC

2023-12-28

Unite Medical® - The Unite Medical® single upright knee orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A single lateral upright design in conjunction with flex-hinge to unload the medial compartment of the knee, helps to promote normal joint movement and reduce pain.

Unite Medical, LLC

2023-12-28

Unite Medical® - The Unite Medical® single upright knee orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A single lateral upright design in conjunction with flex-hinge to unload the medial compartment of the knee, helps to promote normal joint movement and reduce pain.

Unite Medical, LLC

2023-12-28

Unite Medical® - The Unite Medical® suspension sleeve is worn in conjunction with a knee orthosis to help suspend brace and prevent knee orthosis from migrating.

Unite Medical, LLC

2023-12-28

Unite Medical® - The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A double upright design in conjunction with flex-hinge to unload the medial and lateral compartments of the knee, helps to promote normal joint movement and reduce pain.

Unite Medical, LLC

2023-12-28

Unite Medical® - The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A double upright design in conjunction with flex-hinge to unload the medial and lateral compartments of the knee, helps to promote normal joint movement and reduce pain.

Unite Medical, LLC

2023-12-28

Unite Medical® - The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A double upright design in conjunction with flex-hinge to unload the medial and lateral compartments of the knee, helps to promote normal joint movement and reduce pain.

Unite Medical, LLC

2023-12-28

Unite Medical® - The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A double upright design in conjunction with flex-hinge to unload the medial and lateral compartments of the knee, helps to promote normal joint movement and reduce pain.

Unite Medical, LLC

2023-12-28

Unite Medical® - The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A double upright design in conjunction with flex-hinge to unload the medial and lateral compartments of the knee, helps to promote normal joint movement and reduce pain.

Unite Medical, LLC

2023-12-28

Unite Medical® - The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A double upright design in conjunction with flex-hinge to unload the medial and lateral compartments of the knee, helps to promote normal joint movement and reduce pain.

Unite Medical, LLC

2023-12-28

Unite Medical® - The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A double upright design in conjunction with flex-hinge to unload the medial and lateral compartments of the knee, helps to promote normal joint movement and reduce pain.

Unite Medical, LLC

2023-12-28

Unite Medical® - The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A double upright design in conjunction with flex-hinge to unload the medial and lateral compartments of the knee, helps to promote normal joint movement and reduce pain.

Unite Medical, LLC

2023-12-28

Unite Medical® - The Unite Medical® ankle foot orthosis is indicated for ankle instabilities, acute & chronic ankle sprains, hind foot arthritis, ankle tendonitis, and ankle arthritis. The ankle foot orthosis is a lightweight, low profile brace, great for extended wear.

Unite Medical, LLC

2023-12-28

Unite Medical® - The Unite Medical® ankle foot orthosis is indicated for ankle instabilities, acute & chronic ankle sprains, hind foot arthritis, ankle tendonitis, and ankle arthritis. The ankle foot orthosis is a lightweight, low profile brace, great for extended wear.

Unite Medical, LLC

2023-12-28

Unite Medical® - The Unite Medical® ankle foot orthosis is indicated for ankle instabilities, acute & chronic ankle sprains, hind foot arthritis, ankle tendonitis, and ankle arthritis. The ankle foot orthosis is a lightweight, low profile brace, great for extended wear.

Unite Medical, LLC

2023-12-28

Unite Medical® - The Unite Medical® ankle foot orthosis is indicated for ankle instabilities, acute & chronic ankle sprains, hind foot arthritis, ankle tendonitis, and ankle arthritis. The ankle foot orthosis is a lightweight, low profile brace, great for extended wear.

Unite Medical, LLC

2023-12-28

Unite Medical® - The Unite Medical® ankle foot orthosis is indicated for ankle instabilities, acute & chronic ankle sprains, hind foot arthritis, ankle tendonitis, and ankle arthritis. The ankle foot orthosis is a lightweight, low profile brace, great for extended wear.

Unite Medical, LLC

2023-12-28

Unite Medical® - The Unite Medical® ankle foot orthosis is indicated for ankle instabilities, acute & chronic ankle sprains, hind foot arthritis, ankle tendonitis, and ankle arthritis. The ankle foot orthosis is a lightweight, low profile brace, great for extended wear.

Unite Medical, LLC

2023-12-28

Unite Medical® - The Unite Medical® Lumbar Sacral Orthosis is a universal, lightweight spinal orthosis offering anterior, posterior and lateral support.

Unite Medical, LLC

2023-12-28

Unite Medical® - The Unite Medical® Lumbar Sacral Orthosis is a universal, lightweight spinal orthosis offering anterior, posterior and lateral support.

Unite Medical, LLC

2023-12-28