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Pro Comfort Universal Lumbar Support Back Brace

FDA UDI

Class I (US FDA UDI)

by Home Aide Diagnostics, Inc.

Identity

Trade Name
Pro Comfort Universal Lumbar Support Back Brace FDA UDI
Generic Name
Lumbosacral spine orthosis, hernia/ptosis support FDA UDI
Device Name
• 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 FDA UDI
Model / Reference
62350 FDA UDI
Description
• 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 FDA UDI

Identifiers

Catalog Number
7140 FDA UDI
Primary DI / UDI-DI
00850632007140 FDA UDI
FDA Product Code
MRI FDA UDI
GMDN Term
Lumbosacral spine orthosis, hernia/ptosis support FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3490 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Lumbosacral spine orthosis, hernia/ptosis support

Pro Comfort Universal Lumbar Support Back Brace by Home Aide Diagnostics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Lumbosacral spine orthosis, hernia/ptosis support.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Home Aide Diagnostics, Inc.

Sources (1)

  • FDA UDI 4086c9ff-8e83-4000-8546-eb47b903cb0e 35 fields · synced May 30, 2026