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Sign in to claim this brandORTOTECSA SL
US
Last updated May 23, 2026
What ORTOTECSA SL makes
The company manufactures hydrotherapy baths and whirlpool tanks designed for medical and therapeutic use, including mobile and stationary models with varying capacities (ranging from 60L to 1000L). These devices are equipped for different voltage systems (120V or 220V) and include adjustable-height mobile units, as well as specialized tanks like the Hubbard tank with a skimmer system.
The portfolio consists of Class II medical devices, all listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States, adhering to applicable regulatory standards for these hydrotherapy products.
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 Ortotecsa SL manufacture?
Ortotecsa SL specializes in hydrotherapy baths and whirlpool tanks, including both mobile and stationary models. These devices are designed for medical and therapeutic use, with capacities ranging from 60 litres to 1000 litres. The portfolio includes standard whirlpools, adjustable-height mobile units, and specialized tanks like the Hubbard tank with a skimmer system. All devices are tailored for either 120V or 220V electrical systems.
Where is Ortotecsa SL based, and what regulatory standards do they follow?
Ortotecsa SL is based in the United States. Their devices are developed in compliance with applicable U.S. regulatory standards for medical hydrotherapy equipment, ensuring they meet the necessary requirements for safety, performance, and quality. The company adheres to these standards to support the authorised use of their products in clinical settings.
Which regulatory registries list Ortotecsa SL’s devices?
Ortotecsa SL’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class II medical devices, including their hydrotherapy baths and whirlpool tanks, by assigning a unique identifier to each product. The UDI system helps healthcare providers and regulators verify device details and compliance.
How are Ortotecsa SL’s devices classified under medical device regulations?
Ortotecsa SL’s hydrotherapy baths and whirlpool tanks are classified as Class II medical devices. This classification is determined based on their intended use, risk level, and the potential impact on patient safety. Class II devices typically require special controls beyond general controls to ensure their safety and effectiveness, such as performance standards or post-market surveillance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 472631761
Catalogue (25)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Mobile Whirlpool (83l) - 120v | G.18951/B (120V) | FDA UDI | Class II | Active |
| Mobile Whirlpool 230l (60 Gal) - 220v | G.18951/230 | FDA UDI | Class II | Active |
| Stacionary Whirlpool 1000l (264 Gal) – 220v | G.18951/1000 | FDA UDI | Class II | Active |
| Mobile Whirlpool (100l) - 220v | G.18951/C | FDA UDI | Class II | Active |
| Mobile Whirlpool (100l) - 120v | G.18951/C (120V) | FDA UDI | Class II | Active |
| Mobile Whirlpool Adjustable Height (83l) - 220v | G.18951/B-1 | FDA UDI | Class II | Active |
| Mobile Whirlpool (60l) - 120v | G.18951/A (120V) | FDA UDI | Class II | Active |
| Mobile Whirlpool Adjustable Height (83l) - 120v | G.18951/B-1 (120V) | FDA UDI | Class II | Active |
| Mobile Whirlpool 284l (75 Gal) - 120v | G.18951/290 (120V) | FDA UDI | Class II | Active |
| Mobile Whirlpool (83l) - 220v | G.18951/B | FDA UDI | Class II | Active |
| Hubbard Tank With Skimmer | G.18957-A | FDA UDI | Class II | Active |
| Mobile Whirlpool 340l (90 Gal) - 120v | G.18951/340 (120V) | FDA UDI | Class II | Active |
| Mobile Whirlpool (320l) - 220v | G.18951/E | FDA UDI | Class II | Active |
| Stacionary Whirlpool 1000l (264 Gal) – 120v | G.18951/1000 (120V) | FDA UDI | Class II | Active |
| Mobile Whirlpool 230l (60 Gal) - 120v | G.18951/230 (120V) | FDA UDI | Class II | Active |
| Mobile Whirlpool 398l (105 Gal) - 220v | G.18951/400 | FDA UDI | Class II | Active |
| Mobile Whirlpool 398l (105 Gal) - 120v | G.18951/400 (120V) | FDA UDI | Class II | Active |
| Mobile Whirlpool 340l (90 Gal) - 220v | G.18951/340 | FDA UDI | Class II | Active |
| Mobile Whirlpool (170l) - 120v | G.18951/D (120V) | FDA UDI | Class II | Active |
| Mobile Whirlpool Adjustable Height (60l) - 220v | G.18951/A-1 | FDA UDI | Class II | Active |
| Hubbard Tank | G.18957 | FDA UDI | Class II | Active |
| Mobile Whirlpool Adjustable Height (60l) - 120v | G.18951/A-1 (120V) | FDA UDI | Class II | Active |
| Mobile Whirlpool 284l (75 Gal) - 220v | G.18951/290 | FDA UDI | Class II | Active |
| Mobile Whirlpool (60l) - 220v | G.18951/A | FDA UDI | Class II | Active |
| Mobile Whirlpool (320l) - 120v | G.18951/E (120V) | FDA UDI | Class II | Active |
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