FDA classifies medical devices based on the level of risk of harm they present to patients and users. There are three classes, ordered from low to high risk: Class I, II, and III....
Search Results "Significant Risk"
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2.5.1 U.S. Food and Drug Administration
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8.4 Improving Data Sources and Research
with disabilities, perhaps resulting in earlier diagnosis of conditions at more treatable stages than with previous equipment and thus improving patients’ outcome; Decreasing the risks...
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11B-208.2.2 Rehabilitation facilities and outpatient physical therapy facilities
orthopedic conditions that severely limit one's ability to walk; respiratory diseases and other conditions which may require the use of portable oxygen; and cardiac conditions that impose significant...
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M301.1 General (Section-by-Section Analysis)
(Significant Changes – Exception from the Requirements of M301 for Certain Examination Chairs that Comply with M302), in response to public comment and recommendations from the MDE Advisory...
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Title V - Miscellaneous
Some of the significant provisions include: Extension of coverage to the U.S. Congress....
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208.2.2 Rehabilitation Facilities and Outpatient Physical Therapy Facilities
orthopedic conditions that severely limit one's ability to walk; respiratory diseases and other conditions which may require the use of portable oxygen; and cardiac conditions that impose significant...
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Brailling Printed Materials
There is a significant variation in price and quality for producing materials in Braille, depending on turnaround time and the capacity of the providing organization....
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President’s Panel on Mental Retardation
Kennedy creates the President’s Panel on Mental Retardation and calls upon America to address the significant needs of people with intellectual disabilities and their desire to be a part...
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11B-208.2.2 Rehabilitation facilities and outpatient physical therapy facilities
orthopedic conditions that severely limit one's ability to walk; respiratory diseases and other conditions which may require the use of portable oxygen; and cardiac conditions that impose significant...
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11B-208.2.2 Rehabilitation facilities and outpatient physical therapy facilities
orthopedic conditions that severely limit one's ability to walk; respiratory diseases and other conditions which may require the use of portable oxygen; and cardiac conditions that impose significant...
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American Academy for Cerebral Palsy and Developmental Medicine
Developmental Medicine is to provide multidisciplinary scientific education for health professionals and promote excellence in research and services for the benefit of people with and at risk...
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Sizewise Bari Rehab Platform
The Bari Rehab Platform will transport in any high/low position to assist in reducing the risk of caregiver injury and workers’ compensation claims; it will also go into a Cardio Chair position...
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Georgia-Pacific Cormatic® Automated Designer Series Towel Dispenser
Highly durable, long lasting dispenser Customized inserts available Reliable, hygienic touch free dispensing helps reduce risk of cross-contamination Operationally...
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Speakman SensorFlo AC Powered Sensor Faucet S-9020-CA
Perfect for schools, stadiums, and other high risk of vandalism public lavatories, the S-9020 lavatory faucet has all electronics housed above the counter and a metal jacket for the AC transformer...
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Sizewise Evolution
With an 850 pound capacity, and class leading 9” low position the Evolution is a safe option for ‘at risk’ fall patients....
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B. Regulatory Flexibility Act
Flexibility Act (5 U.S.C. 601 et seq.) requires an agency to review regulations to assess their impact on small entities unless the agency determines that a rule is not expected to have a significant...
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Executive Orders 12866 and 13563
Consequently, the Access Board has not determined whether the proposed guidelines are an economically significant regulatory action.48 The Access Board will analyze the information received...
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III-4.3600 Limitations and alternatives
A fundamental alteration is a modification that is so significant that it alters the essential nature of the goods, services, facilities, privileges, advantages, or accommodations offered...
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Merlexi Craft™ Liberty MRI Wheelchairs
MRI Wheelchairs Ensure Patient and Hospital Safety Because traditional MRI wheelchairs look exactly like regular hospital wheelchairs, both patients and hospitals are constantly at risk...
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382.23 May carriers require a passenger with a disability to provide a medical certificate?
., by the carrier’s physician) if the carrier believes either that there has been a significant adverse change in the passenger’s medical condition since the issuance of the medical certificate...
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Breast Platform [M303.4.1]
Members disagreed with limiting the height as the method of minimizing the risk of injury since this could happen at any height depending upon the height of the knees of the person....
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Steelcase Ology Series Height-Adjustable Table
A health-conscious workplace protects the company’s most significant investment and ensures the greatest productivity, efficiency, and innovation possible....
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Section 35.151(g) Assembly areas
The Department received no significant comments on this paragraph and has decided to adopt the proposed language with minor modifications....
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5. The Agreements Lacks Any Mechanism for Monitoring Compliance
While the absence of an effective monitoring program may not alone be a reason to reject the Agreements, the lack of such a program – when coupled with the Agreements’ other significant...
