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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
The ACTIVDAY NO. 501 lumbar-sacral orthosis is designed to support the patient at all stages of his/her recovery. The moldable panels are to be applied post-op without delay for effective immobilization, and kept in place throughout the rehabilitation phase. Later the corset, worn alone, can be adapted to provide comfortable daily support thanks to the progressive immobilization capabilities of our patent pending locking system featuring inter-crossed steps and flexible plastic-covered steel stays. Combined with our comfortable and breathable knitted cotton fabric, you get a result that speaks for itself: Perfect patient compliance. ACTIVDAY NO. 501 consists of 3 separate pieces: A corset fitted with eight (8) flexible steel stays, a covered lumbar thermoplastic panel and an abdominal thermoplastic panel. Indications: • Supports from sacrum to T-9 level. • P ost-op: Following stabilizing surgery, following lumbar disk surgery. • D egenerative pathologies: Osteoporosis, lumbarsacral vertebrae complaint, protrusions, arthritis. • Muscular pathologies: Muscular contractures. • P ractical and easy to fit, it adapts perfectly to your body. • This corset acts as a corrective measure and as a support to postural defects. • Breathable and non allergenic, 100% cotton. • Front panel is 6 3/4” high. FDA UDI
Model / Reference
501 XL FDA UDI
Description
The ACTIVDAY NO. 501 lumbar-sacral orthosis is designed to support the patient at all stages of his/her recovery. The moldable panels are to be applied post-op without delay for effective immobilization, and kept in place throughout the rehabilitation phase. Later the corset, worn alone, can be adapted to provide comfortable daily support thanks to the progressive immobilization capabilities of our patent pending locking system featuring inter-crossed steps and flexible plastic-covered steel stays. Combined with our comfortable and breathable knitted cotton fabric, you get a result that speaks for itself: Perfect patient compliance. ACTIVDAY NO. 501 consists of 3 separate pieces: A corset fitted with eight (8) flexible steel stays, a covered lumbar thermoplastic panel and an abdominal thermoplastic panel. Indications: • Supports from sacrum to T-9 level. • P ost-op: Following stabilizing surgery, following lumbar disk surgery. • D egenerative pathologies: Osteoporosis, lumbarsacral vertebrae complaint, protrusions, arthritis. • Muscular pathologies: Muscular contractures. • P ractical and easy to fit, it adapts perfectly to your body. • This corset acts as a corrective measure and as a support to postural defects. • Breathable and non allergenic, 100% cotton. • Front panel is 6 3/4” high. FDA UDI

Identifiers

Catalog Number
501 FDA UDI
Primary DI / UDI-DI
05391512281250 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 f0fd257f-8a3f-4aed-88c1-e8270c972696 35 fields · synced Jun 1, 2026