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Indego is a computerized, powered exoskeleton, designed to restore walking function for impaired individuals.
Ekso Bionics, Inc.
501-100-000
In Commercial Distribution
- B168501100000 ()
- Programmable ambulation exoskeleton, clinical
The ExoAtlet-II is intended to perform ambulatory functions in rehabilitation institutions, hospitals, or similar institutions under the supervision of a healthcare professional (HCP) such as a trained physical therapist. The ExoAtlet-II is indicated for individuals with spinal cord injuries at levels T4-L5 and individuals with spinal cord injuries at levels of C7-T3. All users must have upper extremity motor function of at least 4/5 in both arms. The ExoAtlet-II is intended for multiple users in a clinical setting (i.e., gait lab or rehabilitation center) under supervision. The ExoAtlet-II includes a battery powered exoskeleton, an ExoCrutch, and a Tablet PC.
ExoAtlet-II is designed to be operated with a trained physical therapist who has received preliminary training on the Exoskeleton operation. This therapist will be familiar with the rules of the use and operational documentation. Training is conducted in a designated medical facility that is representative of the indicated environments (e.g., hospital, outpatient physical therapy clinic or similar). The training identifies safe environments of device use and uses all of the safety features found in the subject device. The training manual will be provided with the user manual along with a trainee itinerary and a trainee certification exam. The trainee needs to pass 80% of the exam questions to obtain certification.
COSMO ROBOTICS CO., Ltd.
EAS010
In Commercial Distribution
- 18800140400031 ()
- Programmable ambulation exoskeleton, clinical
Epicel (cultured epidermal autografts) is an aseptically processed wound dressing composed of the patient’s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts. Epicel consists of sheets of proliferative, autologous keratinocytes, ranging from 2 to 8 cell layers thick and is referred to as a cultured epidermal autograft. Each graft of Epicel is attached to petrolatum gauze backing with titanium surgical clips and measures a minimum of 50 cm2 in area.
Epicel is authorized by Federal law for use in adult and pediatric patients who have deep dermal or full-thickness burns comprising a total body surface area greater than or equal to 30%. Epicel may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.
VERICEL CORPORATION
N/A
In Commercial Distribution
- W41020AU201S1969 ()
- Area/Surface Area: 50 Square centimeter
- Cultured skin autograft/xenograft
Epicel (cultured epidermal autografts) is an aseptically processed wound dressing composed of the patient’s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts. Epicel consists of sheets of proliferative, autologous keratinocytes, ranging from 2 to 8 cell layers thick and is referred to as a cultured epidermal autograft. Each graft of Epicel is attached to petrolatum gauze backing with titanium surgical clips and measures approximately 50 cm2 in area.
Epicel is authorized by Federal law for use in adult and pediatric patients who have deep dermal or full-thickness burns comprising a total body surface area greater than or equal to 30%. Epicel may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.
VERICEL CORPORATION
0
In Commercial Distribution
- W41020AU201P0001 ()
- Area/Surface Area: 50 Square centimeter
- Cultured skin autograft/xenograft
Gait Belt- Plastic Buckle, Multi-Color, 60"x2"
Dynarex Corporation
4354
In Commercial Distribution
- 00616784435435 ()
- 00616784435411 ()
- Gait rehabilitation system harness
Gait Belt, Metal Buckle, Multi-color, 60"x2"
Dynarex Corporation
4353
In Commercial Distribution
- 00616784435336 ()
- 00616784435312 ()
- Gait rehabilitation system harness
Gait Belt- Metal Buckle, Natural Color, 60"x2"
Dynarex Corporation
4352
In Commercial Distribution
- 00616784435237 ()
- 00616784435213 ()
- Gait rehabilitation system harness
GAIT BELT,YELLOW,FALL MGMT,72" 1EA
MEDLINE INDUSTRIES, INC.
MDT821203YL
In Commercial Distribution
- 10080196374779 ()
MDT821203YL
- Gait rehabilitation system harness
PUMP 8637-20 SYNCHMED II 20ML PF
MEDTRONIC, INC.
8637-20
In Commercial Distribution
- 00643169100831 ()
- Total Volume: 20.0 Milliliter
- Implantable intrathecal infusion pump, programmable
PUMP 8637-40 SYNCHMED II 40ML PF
MEDTRONIC, INC.
8637-40
In Commercial Distribution
- 00643169100824 ()
- Total Volume: 40.0 Milliliter
- Implantable intrathecal infusion pump, programmable