One manufacturer commented on this provision, asserting that the proposed requirement was unclear and should clearly state that the diagnostic equipment only has to be compatible with either...
Search Results "Manufacturer"
-
M301.4 Lift Compatibility (Section-by-Section Analysis)
-
8.3 Alternate Means of Access
Although current technical requirements may prevent compliance with recommended access standards (see Section 7 for examples), Committee members aimed to encourage manufacturers and developers...
-
Conclusions
The results of these studies could help airline, motor vehicle, amusement park ride, and adaptive equipment manufacturers to improve and create designs that facilitate the transfer process...
-
T303 Handrails, Stanchions, and Handholds
A seating manufacturer expressed concern that larger diameter handholds would result in significant industry-wide expense and lead to potential safety issues because greater rigidity would...
-
3.6.1. Hardware Replacement
Public comments on the 2014 NPRM, as well as information provided by manufacturers, suggest that captioning and audio description hardware is expected to last about 10 years. ...
-
Positioning Supports Considered
b) What would be the incremental costs for the design or redesign and manufacture of positioning supports?...
-
Other relevant federal rules and guidance documents
The FDA-CDRH may develop a guidance document to inform manufacturers how it intends to apply its regulatory authority to clearance or approval of medical devices addressed in the Access...
-
1023.9 Stairway identification signs
Architects, Signage Consultants and Manufacturers having standard details showing one sign for both purposes are encouraged to change them permanently, indicating two separate and distinct...
-
1023.9 Stairway identification signs
Architects, Signage Consultants and Manufacturers having standard details showing one sign for both purposes are encouraged to change them permanently, indicating two separate and distinct...
-
Breast Platform [M303.4.1]
According to industry, equipment currently manufactured ranges anywhere between 25 and 28 inches for the lowest measurement of the breast platform....
-
7.1 Basic Understanding of Diagnostic Imaging Equipment
Manufacturers, however, hold a different understanding, founded upon existing FDA definitions (see below)....
-
Preliminary Guidelines for SEWF Installation
Follow manufacturer's instructions for storage and handling of the binder. Binder materials must be stored indoors in cool dry storage out of sunlight....
-
Accessible golf cars. (Section-by-Section Analysis)
An accessible golf car means a device that is designed and manufactured to be driven on all areas of a golf course, is independently usable by individuals with mobility disabilities, has...
-
C103 Defined Terms (Section-by-Section Analysis)
This term is newly defined in order to provide consistent cross-reference within the guidelines to all chapters that apply to Section 255-covered manufacturers of telecommunications equipment...
-
Findings
Occurrences were identified in the sample where the surface material installation did not parallel either the manufacturer’s installation instructions or the procedural instructions on the...
-
2.3 Infrared (IR) Systems
The specific bandwidth of the IR carrier varies among manufacturers; it may be as narrow as 50 nm wide, or considerably broader and perhaps be visible as a faint reddish glow (Laszlo l998...
-
Accessible golf cars (Section-by-Section Analysis)
An accessible golf car means a device that is designed and manufactured to be driven on all areas of a golf course, is independently usable by individuals with mobility disabilities, has...
-
Deltrex D106 Series Push Plate Switch
A full list of customizable options are available Features All manufactured with rust resistant 1/4" inch aluminum Non-binding internal stainless steel screws Tested for 1,000,000,000...
-
Deltrex F106 Series Push Plate Switch
Features All manufactured with rust resistant 1/4" inch aluminum Non-binding internal stainless steel screws Tested for 1,000,000,000 pushes...
-
Irwin Seating Company ADA Swing-Away Aisle Panels
Many aisle end panels can be manufactured to swing open to allow an individual to transfer between a wheelchair and the theatre chair....
-
Running Slope of Ramps Deployed to Roadways or Curb-Height Bus Stops
Second, low floor bus technologies had rapidly evolved and all major domestic bus manufacturers offered one or more models....
-
DORMA M9000 Series Heavy-Duty Mortise Locksets
Product features With a heavy-duty mortise chassis Including special, high-strength springs Select components manufactured with high-strength steel or stainless steel, providing...
-
M301.3.1 Transfer Supports
These requirements are already addressed by international standards that medical device manufacturers need to follow (e.g. risk management (ISO 14971); IEC60601-1; and use of IEC60601-2-...
-
Implications
Proper installation in accordance to the manufacturer’s instructions, per the standards, and by experienced personnel is critical. ...
