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Activday

FDA UDI

Class I (US FDA UDI)

by Indaco Srl

Identity

Trade Name
ACTIVDAY FDA UDI
Generic Name
Lumbar spine orthosis FDA UDI
Device Name
This ACTIVDAY Lumbar-Sacral 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 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. Two rigid thermo-formable panels for lumbar and abdominal application are included. These panels produce intra-abdominal pressure to reduce load on discs thus reducing pain and improving post-operative outcome when used with the corset in the appropriate position. The supported region extends from the sacrococcygeal joint to T-9 vertebra. Practical and easy to wear, this 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 •Lumbago, sciatica and ischialgia.. •Lumbar-Sacral pain of other origin and nature. •Disc complaints. •Spondylo-arthrosis. •Osteoporosis related lumbar vertebrae complaints. •Para-vertebral lumbar muscle spasm. •Light trauma of the lumbar-sacral column. FDA UDI
Model / Reference
500 3XL FDA UDI
Description
This ACTIVDAY Lumbar-Sacral 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 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. Two rigid thermo-formable panels for lumbar and abdominal application are included. These panels produce intra-abdominal pressure to reduce load on discs thus reducing pain and improving post-operative outcome when used with the corset in the appropriate position. The supported region extends from the sacrococcygeal joint to T-9 vertebra. Practical and easy to wear, this 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 •Lumbago, sciatica and ischialgia.. •Lumbar-Sacral pain of other origin and nature. •Disc complaints. •Spondylo-arthrosis. •Osteoporosis related lumbar vertebrae complaints. •Para-vertebral lumbar muscle spasm. •Light trauma of the lumbar-sacral column. FDA UDI

Identifiers

Catalog Number
500 FDA UDI
Primary DI / UDI-DI
05391512281205 FDA UDI
FDA Product Code
IPY 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

Activday 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 bce79760-159d-422b-a9fe-54fa97ff8fc9 35 fields · synced May 30, 2026