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M-Brace Air

FDA UDI

Class I (US FDA UDI)

by Indaco Srl

Identity

Trade Name
M-Brace Air FDA UDI
Generic Name
Lumbar spine orthosis FDA UDI
Device Name
This Lumblock Lumbar Brace acts as an immobilizing device for the lumbar-sacral region and its’ primary function is to reduce pain caused by lumbago, sciatica and ischialgia. Made with semi-rigid cotton fabric, it enjoys a structure made with eight self modeling and flexible steel stays on which a number of rigid straps slide. When the locking system is pulled and secured at the front, the inside straps stiffen the entire structure, thus effectively immobilizing the lumbar-sacral region. Practical and easy to wear, this Lumblock back brace perfectly adapts to whatever size and body type, thus ensuring maximum support and comfort at the desired tension. Through a new locking technology, operated by means of two crossing bands, the closing system is totally user friendly and allows a wide range of elastic tension settings. INDICATIONS • Postural pathologies: Lumbago, sciatica, discopathy, hypo-lordosis. • Degenerative pathologies: Osteoporosis, vertebrae complaints, protrusions, arthrosis. • Muscular pathologies: Muscular contractures. • Practical and easy to fit, it adapts perfectly to your body. • Breathable and non allergenic. • Front is 6 3/4”high. • Back is 10 1/2”high. FDA UDI
Model / Reference
582 XL FDA UDI
Description
This Lumblock Lumbar Brace acts as an immobilizing device for the lumbar-sacral region and its’ primary function is to reduce pain caused by lumbago, sciatica and ischialgia. Made with semi-rigid cotton fabric, it enjoys a structure made with eight self modeling and flexible steel stays on which a number of rigid straps slide. When the locking system is pulled and secured at the front, the inside straps stiffen the entire structure, thus effectively immobilizing the lumbar-sacral region. Practical and easy to wear, this Lumblock back brace perfectly adapts to whatever size and body type, thus ensuring maximum support and comfort at the desired tension. Through a new locking technology, operated by means of two crossing bands, the closing system is totally user friendly and allows a wide range of elastic tension settings. INDICATIONS • Postural pathologies: Lumbago, sciatica, discopathy, hypo-lordosis. • Degenerative pathologies: Osteoporosis, vertebrae complaints, protrusions, arthrosis. • Muscular pathologies: Muscular contractures. • Practical and easy to fit, it adapts perfectly to your body. • Breathable and non allergenic. • Front is 6 3/4”high. • Back is 10 1/2”high. FDA UDI

Identifiers

Catalog Number
582 FDA UDI
Primary DI / UDI-DI
05391512280918 FDA UDI
FDA Product Code
IQE FDA UDI
GMDN Term
Lumbar spine orthosis 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Category: Lumbar spine orthosis

M-Brace Air by Indaco Srl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Lumbar spine orthosis.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Indaco Srl

Sources (1)

  • FDA UDI 5430d37b-07ab-4fee-9519-a936ae844fae 35 fields · synced May 30, 2026