CE Certified
Arm Prosthesis Cable Control Style Prosthetic Hand & Mechanic Above Elbow Arm
- Body-powered cable harness system
- Stainless steel modular skeleton
- High-durability friction wrist unit
Direct factory supply of CE Class I certified spinal-hip-knee-foot orthoses (SHKAFO), dynamic AFOs, myoelectric limbs, and modular bionic upper extremity components engineered for high clinical efficacy.
In modern biomechanical rehabilitation, the Spinal Hip Knee Foot Orthosis (SHKAFO) represents the pinnacle of non-invasive lower extremity and axial skeletal stabilization. Designed to mitigate severe paraplegia, spinal cord injuries (SCI at levels T6 to L2), myelomeningocele (Spina Bifida), and extensive neuromuscular degeneration, a high-performance SHKAFO integrates full-body structural kinematic control from the thoracic spine down to the plantar surface of the foot.
As a leading CE-certified manufacturer and OEM factory supplying the Los Angeles and broader Southern California markets, Singar Rehab engineers orthotic systems that reconcile rigid structural support with patient gait economy. By utilizing high-density Polypropylene Copolymer (PPCP), custom-molded carbon-fiber composite laminates, and aerospace-grade duralumin uprights, our manufacturing process yields structural integrity capable of sustaining repetitive ground reaction forces (GRF) while minimizing gross orthotic weight.
Our OEM manufacturing facility operates strictly under ISO 13485:2016 quality management protocols. Every unit destined for California medical facilities features standardized components compliant with U.S. orthotic billing guidelines (HCPCS L-Codes L2005, L2036, L2037):
| Anatomical Segment | Structural Material | Kinematic Mechanism | Clinical Function |
|---|---|---|---|
| Spinal / Pelvic Band | Thermoformed PPCP & Perforated EVA Lining | Rigid Thoracolumbar (TLSO) Extension Rods | Prevents excessive lordosis/kyphosis, controls pelvic rotation and lumbar posture. |
| Hip Joint Unit | Titanium Alloy / Drop-Lock Steel Joints | Multi-position Ratchet or Free-Motion Lock | Stabilizes sagittal plane hip extension while allowing controlled sitting flexion. |
| Knee Control Assembly | Aircraft Duralumin / Forged Stainless Steel | Swiss Ring Lock or Offset Knee Joint | Prevents hyperextension (genu recurvatum) and ensures automatic stance-phase locking. |
| Ankle-Foot (AFO) | Carbon-Fiber Composite & High-Impact Polypropylene | Posterior Leaf Spring / Rigid Solid Ankle | Corrects foot-drop, stabilizes subtalar inversion/eversion, aids push-off phase. |
The Greater Los Angeles healthcare network—encompassing renowned research hospitals, acute rehabilitation trauma centers, and specialized outpatient orthotic networks—demands orthotic devices that meet strict clinical, durability, and insurance-reimbursement criteria. Factory-direct sourcing of CE-marked SHKAFO devices allows Southern California clinics to provide custom-fitted, high-tier rehabilitative care while controlling procurement costs.
Utilized in major trauma facilities like Cedars-Sinai and UCLA Health for post-acute spinal injury stabilization. Early orthotic mobilization with our rigid SHKAFO prevents muscle contractures, preserves bone mineral density, and facilitates early upright gait training.
Custom pediatric SHKAFO variants supplied to Los Angeles specialized pediatric care centers. The modular, growth-accommodating upright designs allow orthotists to lengthen structural struts as pediatric patients grow, optimizing lifetime clinical investment.
Veterans suffering from blast polytrauma, spinal cord compression, or complex motor neuropathies require extreme-duty bracing. Our duralumin-reinforced SHKAFOs provide military-grade reliability and low maintenance for active veteran rehabilitation programs.
Independent prosthetists and orthotists across LA County rely on our pre-fabricated component kits and thermoformable blanks. Pre-tested according to ISO 10328 structural standards, these systems support seamless Medicare/Medi-Cal billing authorization.
The Southern California orthotics market is rapidly phasing out traditional heavy metal-and-leather calipers in favor of vacuum-formed polypropylene copolymer (PPCP) and pre-preg carbon fiber composites. Clinicians in Los Angeles prioritize weight reduction to lower oxygen consumption during ambulation. Our factory utilizes high-grade thermoplastic extrusion, ensuring that all orthotic shells exhibit non-brittle impact resistance, smooth finish for skin-contact hygiene, and heat-moldability for in-clinic adjustments.
Navigating medical device import into California requires stringent regulatory harmonization. While CE certification (under EU Regulation 2017/745) ensures compliance with European health, safety, and environmental protection standards, U.S. buyers in Los Angeles require manufacturers to maintain complete technical documentation, Device Master Records (DMR), and biocompatibility testing (ISO 10993) for skin-contacting materials. As a globally accredited manufacturer, Singar Rehab provides full regulatory dossier packages for seamless clearance at the Port of Los Angeles and Port of Long Beach customs checkpoints.
Modern polytrauma patients frequently present with multi-limb paralysis or amputation. The trend in Los Angeles neuro-rehabilitation centers favors integrated clinical sourcing—procuring both lower extremity SHKAFO/HKAFO bracing and advanced myoelectric upper extremity limbs (such as our 2-DOF Myoelectric Arm and RS485 Bionic Humanoid Hand) from a unified OEM source. This reduces supply chain complexity and standardizes battery/sensor components across the patient's assistive technology suite.
Established in 2005, Singar Rehab operates an advanced manufacturing facility dedicated to orthotic and prosthetic engineering. Serving over 500 clinical institutions across 20+ countries, our factory blends automated CNC machining, custom plaster-to-CAD positive modeling, and manual craftsmanship to yield medical devices of unmatched reliability.
Yes. All SHKAFO units, dynamic AFOs, and prosthetic assemblies manufactured by Singar Rehab carry CE Class I medical device certification conforming to European MDR standards and international ISO 13485 quality frameworks, ensuring full compliance for international import into the United States and California markets.
For urgent clinical samples or custom patient orders, expedited air freight directly to Los Angeles International Airport (LAX) takes 5 to 7 business days. For bulk wholesale freight shipments delivered via the Port of Los Angeles or Port of Long Beach, transit times range from 18 to 22 calendar days.
Yes. Our modular componentry (including pelvic bands, drop-lock hip joints, offset knee joints, and rigid AFO footplates) aligns structurally with standard U.S. billing codes (such as L2005 for SHKAFO full body, L2036/L2037 for knee-ankle-foot orthoses). We provide detailed material spec sheets to assist California orthotists with insurance documentation.
Absolutely. We specialize in both standardized sizing kits and custom-mold manufacturing. Orthotists in Greater Los Angeles can submit digital 3D STL scan files, plaster cast measurements, or physical negative molds to our engineering team for custom thermoforming and structural alignment.
We utilize virgin medical-grade Polypropylene Copolymer (PPCP), hypoallergenic closed-cell EVA lining foams, and aerospace duralumin/titanium joint alloys. All skin-contacting polymers undergo strict biocompatibility testing to prevent skin breakdown during extended wearing periods.
For modular components and standardized orthoses, our MOQ starts at just 5 units per size. For custom OEM branding or full-system SHKAFO manufacturing, we offer flexible tier-based wholesale pricing designed to accommodate both small private O&P labs and large hospital purchasing groups.