Pro Comfort Universal Lumbar Support Back Brace 7140

GUDID 10850632007147

• User for: Postural support, Chronic back pain, Lumbar strains or sprains, Post operative rehabilitation, Lumbar instability • The Pro Comfort Back Brace provides stabilization of the spine and restriction of the pelvis. This, in turn, relieves the pressure on the lumbar discs which helps alleviate pain and increase rehabilitation. • The ergonomic design allows it to be comfortably worn under clothing. • One Size fits all. Adjustable Size

HOME AIDE DIAGNOSTICS, INC.

Lumbosacral spine orthosis, hernia/ptosis support
Primary Device ID10850632007147
NIH Device Record Key4086c9ff-8e83-4000-8546-eb47b903cb0e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePro Comfort Universal Lumbar Support Back Brace
Version Model Number62350
Catalog Number7140
Company DUNS783518983
Company NameHOME AIDE DIAGNOSTICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone18009150116
Emailinfo@homeaide.us

Device Identifiers

Device Issuing AgencyDevice ID
GS100850632007140 [Primary]
GS110850632007147 [Package]
Contains: 00850632007140
Package: Outer Case [20 Units]
In Commercial Distribution

FDA Product Code

MRIOrthosis, Truncal/Orthosis, Limb

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-07
Device Publish Date2018-08-07

Devices Manufactured by HOME AIDE DIAGNOSTICS, INC.

10850027494507 - True Support Neck Brace2023-11-13 Universal Neck Brace
10850027494514 - Smart Neb Pediatric Nebulizer2023-11-13 Smart Neb Pediatric Nebulizer
10850027494866 - True Comfort Safety Insulin Syringes 30g 1/2" 1/2cc2023-11-13 100 * Safety Insulin Syringes 30g 1/2" 1/2cc
10850027494873 - True Comfort Safety Insulin Syringes 30g 1/2" 1cc2023-11-13 100 * Safety Insulin Syringes 30g 1/2" 1cc
10850027494880 - True Comfort Safety Insulin Syringes 30g 5/16'' 1/2cc2023-11-13 100 * Safety Insulin Syringes 30g 5/16'' 1/2cc
10850027494897 - True Comfort Safety Insulin Syringes 30g 5/16'' 1cc2023-11-13 100 * Safety Insulin Syringes 30g 5/16'' 1cc
10850027494903 - True Comfort Safety Insulin Syringes 31g 5/16" 1/2cc2023-11-13 100 * Safety Insulin Syringes 31g 5/16" 1/2cc
10850027494910 - True Comfort Safety Insulin Syringes 31g 5/16" 1cc2023-11-13 100 * Safety Insulin Syringes 31g 5/16" 1cc

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.