ACTIVDAY

Primary DI
05391512285968
Brand
ACTIVDAY
Company
INDACO SRL
Model
500 M
Catalog number
500
Device 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.
Published
2024-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
IPYOrthosis, Lumbo-Sacral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPYOrthosis, Lumbo-SacralPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391512285968PackageGS110In Commercial Distribution
05391512281168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391512285968053915122859685391512285968
05391512281168053915122811685391512281168

GMDN Terms#

Term, Definition table
TermDefinition
Lumbar spine orthosisA prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to encompass the lumbar spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-866-374-4050contact@m-brace.com

Regulatory Flags#

DUNS number
338470646
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
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05391512281021M-Brace Air576 S5762024-02-15
05391512281038M-Brace Air576 M5762024-02-15
05391512281045M-Brace Air576 L5762024-02-15
05391512281052M-Brace Air576 XL5762024-02-15
05391512281441M-Brace Air576 XXL5762024-02-15
05391512282905HPH Corp.648K size 26648K2024-04-04
05391512282912HPH Corp.648K size 28648K2024-04-04
05391512282929HPH Corp.648K size 30648K2024-04-04
05391512282936HPH Corp.648K size 32648K2024-04-04
05391512282943HPH Corp.648K size 34648K2024-04-04
05391512282950HPH Corp.648K size 36648K2024-04-04
05391512282967HPH Corp.648K size 38648K2024-04-04
05391512282974HPH Corp.648K size 40648K2024-04-04
05391512282981HPH Corp.648K size 42648K2024-04-04
05391512282998HPH Corp.648K size 44648K2024-04-04
05391512283001HPH Corp.648K size 46648K2024-04-04
05391512283018HPH Corp.648K size 48648K2024-04-04
05391512283025HPH Corp.648K size 50648K2024-04-04
05391512283032HPH Corp.648K size 52648K2024-04-04
05391512283049HPH Corp.648K size 54648K2024-04-04

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