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Sign in to claim this brandINDACO SRL
US
Last updated May 24, 2026
What INDACO SRL makes
Indaco Srl manufactures reusable and non-reusable orthopedic supports, including lumbar spine orthoses like the M-Brace Air, clavicle orthoses, and abdominal hernia trusses such as the HPH Corp. and BEST BACK. Their portfolio also includes wrist/hand orthoses, metacarpophalangeal joint extension braces, knee supports, and reusable abdominal and ankle binders like the ACTIVDAY. These devices are designed to provide external support, stabilization, or compression for musculoskeletal conditions.
The company’s products are classified as Class I medical devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. Indaco Srl operates from the United States, adhering to applicable U.S. regulatory requirements for these orthopedic supports.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Indaco Srl manufacture?
Indaco Srl specializes in orthopedic supports, including lumbar spine orthoses (like the M-Brace Air), clavicle orthoses, and abdominal hernia trusses (such as HPH Corp. and BEST BACK). Their portfolio also covers wrist/hand orthoses, metacarpophalangeal joint extension braces, knee supports, and reusable abdominal/ankle binders (e.g., ACTIVDAY). These devices are designed to provide external support, stabilization, or compression for musculoskeletal conditions.
Where is Indaco Srl based, and how does that affect its regulatory compliance?
Indaco Srl is based in the United States, meaning its devices must comply with U.S. regulatory requirements. Since these products are classified as Class I medical devices under FDA regulations, they fall under the FDA’s general controls, which include registration, listing, and UDI requirements. The company’s location ensures alignment with FDA-specific processes for device authorization.
Are Indaco Srl’s devices listed in any regulatory databases, and why does that matter?
Yes, Indaco Srl’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This matters because the UDI system ensures traceability, transparency, and efficient tracking of medical devices throughout their lifecycle. Listing in the UDI database helps healthcare providers, regulators, and patients verify device details, reducing risks like counterfeiting or misidentification.
How are Indaco Srl’s devices classified, and what does that classification imply?
Indaco Srl’s devices are classified as Class I under FDA regulations, which is the lowest risk category. This classification implies that the devices pose minimal potential harm and are subject to general controls like good manufacturing practices (GMP), registration, and UDI requirements. Class I devices typically require less rigorous premarket review unless they are custom-designed or present higher risks.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- m-brace.com
- —
- —
- [email protected]
- Phone
- 866-374-4050
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 338470646
Catalogue (262)
Page 1 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| M-Brace Air | 41 XXL | FDA UDI | Class I | Active |
| HPH Corp. | 648K size 44 | FDA UDI | Class I | Active |
| M-Brace Air | 43 M | FDA UDI | Class I | Active |
| Best Back | 007 size XXXL IRON | FDA UDI | Class I | Active |
| M-Brace Air | 610 XL | FDA UDI | Class I | Active |
| M-Brace Air | 630 2XL/3XL | FDA UDI | Class I | Active |
| M-Brace Air | 134 RE | FDA UDI | Class I | Active |
| M-Brace Air | 17 L | FDA UDI | Class I | Active |
| M-Brace Air | 137 L | FDA UDI | Class I | Active |
| M-Brace Air | 46 RXXL | FDA UDI | Class I | Active |
| Activday | 500 L | FDA UDI | Class I | Active |
| Activday | 501 XL | FDA UDI | Class I | Active |
| HPH Corp. | 648K size 38 | FDA UDI | Class I | Active |
| Activday | 501 XXL | FDA UDI | Class I | Active |
| HPH Corp. | 672K size 32 | FDA UDI | Class I | Active |
| HPH Corp. | 672K size 36 | FDA UDI | Class I | Active |
| Best Back | 007 size S DENIM | FDA UDI | Class I | Active |
| M-Brace Air | 574 S | FDA UDI | Class I | Active |
| HPH Corp. | 648K h12 size 26 | FDA UDI | Class I | Active |
| HPH Corp. | 648K h12 size 32 | FDA UDI | Class I | Active |
| HPH Corp. | 672K size 46 | FDA UDI | Class I | Active |
| M-Brace Air | 134 RR | FDA UDI | Class I | Active |
| M-Brace Air | 16 L | FDA UDI | Class I | Active |
| Activday | 501 4XL | FDA UDI | Class I | Active |
| Best Back | 007 size XS DENIM | FDA UDI | Class I | Active |
| HPH Corp. | 648K h12 size 48 | FDA UDI | Class I | Active |
| M-Brace Air | 594 M | FDA UDI | Class I | Active |
| M-Brace Air | 46 RS | FDA UDI | Class I | Active |
| Best Back | 007 size L ORANGE | FDA UDI | Class I | Active |
| Best Back | 007 size S LADY | FDA UDI | Class I | Active |
| M-Brace Air | 584 L | FDA UDI | Class I | Active |
| Best Back | 007 size XXL ORANGE | FDA UDI | Class I | Active |
| M-Brace Air | 80 R | FDA UDI | Class I | Active |
| HPH Corp. | 648K size 28 | FDA UDI | Class I | Active |
| Best Back | 007 size XL DENIM | FDA UDI | Class I | Active |
| M-Brace Air | 136 LE | FDA UDI | Class I | Active |
| HPH Corp. | 672K size 40 | FDA UDI | Class I | Active |
| M-Brace Air | 46 LS | FDA UDI | Class I | Active |
| M-Brace Air | 572 XXL | FDA UDI | Class I | Active |
| M-Brace Air | 573 XS | FDA UDI | Class I | Active |
| HPH Corp. | 648K size 42 | FDA UDI | Class I | Active |
| Activday | 502 XXL | FDA UDI | Class I | Active |
| M-Brace Air | 505 2XL/3XL | FDA UDI | Class I | Active |
| M-Brace Air | 584 XS | FDA UDI | Class I | Active |
| M-Brace Air | 46 LM | FDA UDI | Class I | Active |
| M-Brace Air | 630 S/M | FDA UDI | Class I | Active |
| Best Back | 007 size S IRON | FDA UDI | Class I | Active |
| M-Brace Air | 584 3XL | FDA UDI | Class I | Active |
| Best Back | 007 size S ORANGE | FDA UDI | Class I | Active |
| M-Brace Air | 503 S/M | FDA UDI | Class I | Active |
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