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 ID: 10850632007147
• NIH Device Record Key: 4086c9ff-8e83-4000-8546-eb47b903cb0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pro Comfort Universal Lumbar Support Back Brace
• Version Model Number: 62350
• Catalog Number: 7140
• Company DUNS: 783518983
• Company Name: HOME AIDE DIAGNOSTICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 18009150116
• Email: info@homeaide.us

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850632007140 [Primary]
GS1	10850632007147 [Package]; Contains: 00850632007140; Package: Outer Case [20 Units]; In Commercial Distribution

FDA Product Code

• MRI: Orthosis, Truncal/Orthosis, Limb

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-07
• Device Publish Date: 2018-08-07

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