drmarty
04-07-2007, 05:08 PM
A while ago a point was made that The Mouse or someone refused Segways because the accepted definition of a "Wheelchair" was a 3 or 4 wheeled device and Segways only had 2. That definition was supposedly from somewhere in our federal government.
Well I was lurking around and found this and copied it. It is from the Code of Federal Regulations as it states. It's location is included.
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2006]
[CITE: 21CFR890.3850]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 890 -- PHYSICAL MEDICINE DEVICES
Subpart D--Physical Medicine Prosthetic Devices Sec. 890.3850 Mechanical wheelchair.
(a) Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.
(b) Classification. Class I (general controls).
Database Updated April 1, 2006
Ok. It appears as of 1 April, 2006 (no this is not an April fools joke. That really is the date it was updated) that the definition has been broadened. In searching I think this was from an ANSI meeting and is part of their "Recognized Consensus Standards" and is Item 49: ANSI / RESNA WC/Volume 1 - 1998, Section 0: Nomenclature, Terms, and Definitions. (Physical Medicine)
It is a little hard to tell because ANSI wants $54 for their information. Not likely!
Next and this is interesting, when you want to build and sell a wheelchair like all those sitting at the front of Dizzyland or in malls or stores, you do not have to prove it is OK. What you do have to do is compare it to an already approved device and show it is as good or better. This makes sense as the cost to do the testing would be prohibitive for many items. So what you do is submit a 510(K) request for approval to sell your new whizbang wheelchair or widget.
Stay with me. Here it comes --
Part of this application is your intended "Indications for Use" and then at the end of the 510(K) application the approved "Indications for Use" Here are just some of these. They are all boilerplate it seems so if you look at a bunch, and I did, you will find they vary little.
Device Name: Broda Model 587 Manual Wheelchair
Indications For Use: The intended use of the Broda Model 587 Manual
Wheelchair is to provide mobility to persons that may be
limited to a sitting position.
Device Name:
Proprietary Name: MAXHEALTH Mechanical Wheelchair, KL
Common or Usual Name: Mechanical Wheelchair
Classification Name: Mechanical Wheelchair, Class J,
21 CFR 890.3850
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted
to a seated position.
Device Name: NISSIN Pediatric Series Wheelchair
Indications For use: The NISSIN Pediatric Series Wheelchair is intended to be
used to empower persons physically challenged to a sitting position by providing
a means of mobility.
Device Name: AXS Transport Chair
Indications for Use: AXS Transport Chairs are indicated for providing mobility
to persons limited to a sitting position
DEVICE NAME: PRO WALKER ML-300 Foldable Wheelchair
INDICATIONS FOR USE:
The device is intended for medical purposes to provide mobility to persoi~
restricted to a sitting position.
DEVICE NAME: SINON SN-L402 Lightweight Wheelchair
INDICATIONS FOR USE:
The device is intended for medical purposes to provide mobility to person
restricted to a sitting position.
This brings up 2 points. One is labelling. It states in there that our friendly "to be prescribed only by a doctor" statement IS required. The following is from the:
"Guidance Document For the Preparation of
Premarket Notification [510(K)] Applications For
Mechanical and Powered Wheelchairs, and
Motorized Three-Wheeled Vehicles"
Provide the following prescription statement (both on the device itself and in the operator's manual, and in any advertising and/or promotional materials) according to 21 CFR 801.109:
Caution: Federal law restricts this device to sale by or on the order of a practitioner licensed by the law of the State in which he/she practices."
And almost all of them use and then are approved for persons that are "restricted to a sitting position." This does not fit many Segway users who use them as a mobility aid but does point up why you should not just have a herd of wheelchairs of unknown safety , maintanence, and cleanliness sitting at the door to be prescribed for use by the Greeter, Guard, Asst Manager, Janitor or whoever is at the door.
Remember that at this point we are talking only about Wheelchair regulations, not Segway regulations. This information is only to point out that when someone is offered a wheelchair (like the recent case where a lawsuit has been filed against a shopping mall. That information has been posted in this section) that the person offering the wheelchair is very likely practicing medcine without a license or doing some other bad thing.
More to come.
Marty
Well I was lurking around and found this and copied it. It is from the Code of Federal Regulations as it states. It's location is included.
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2006]
[CITE: 21CFR890.3850]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 890 -- PHYSICAL MEDICINE DEVICES
Subpart D--Physical Medicine Prosthetic Devices Sec. 890.3850 Mechanical wheelchair.
(a) Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.
(b) Classification. Class I (general controls).
Database Updated April 1, 2006
Ok. It appears as of 1 April, 2006 (no this is not an April fools joke. That really is the date it was updated) that the definition has been broadened. In searching I think this was from an ANSI meeting and is part of their "Recognized Consensus Standards" and is Item 49: ANSI / RESNA WC/Volume 1 - 1998, Section 0: Nomenclature, Terms, and Definitions. (Physical Medicine)
It is a little hard to tell because ANSI wants $54 for their information. Not likely!
Next and this is interesting, when you want to build and sell a wheelchair like all those sitting at the front of Dizzyland or in malls or stores, you do not have to prove it is OK. What you do have to do is compare it to an already approved device and show it is as good or better. This makes sense as the cost to do the testing would be prohibitive for many items. So what you do is submit a 510(K) request for approval to sell your new whizbang wheelchair or widget.
Stay with me. Here it comes --
Part of this application is your intended "Indications for Use" and then at the end of the 510(K) application the approved "Indications for Use" Here are just some of these. They are all boilerplate it seems so if you look at a bunch, and I did, you will find they vary little.
Device Name: Broda Model 587 Manual Wheelchair
Indications For Use: The intended use of the Broda Model 587 Manual
Wheelchair is to provide mobility to persons that may be
limited to a sitting position.
Device Name:
Proprietary Name: MAXHEALTH Mechanical Wheelchair, KL
Common or Usual Name: Mechanical Wheelchair
Classification Name: Mechanical Wheelchair, Class J,
21 CFR 890.3850
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted
to a seated position.
Device Name: NISSIN Pediatric Series Wheelchair
Indications For use: The NISSIN Pediatric Series Wheelchair is intended to be
used to empower persons physically challenged to a sitting position by providing
a means of mobility.
Device Name: AXS Transport Chair
Indications for Use: AXS Transport Chairs are indicated for providing mobility
to persons limited to a sitting position
DEVICE NAME: PRO WALKER ML-300 Foldable Wheelchair
INDICATIONS FOR USE:
The device is intended for medical purposes to provide mobility to persoi~
restricted to a sitting position.
DEVICE NAME: SINON SN-L402 Lightweight Wheelchair
INDICATIONS FOR USE:
The device is intended for medical purposes to provide mobility to person
restricted to a sitting position.
This brings up 2 points. One is labelling. It states in there that our friendly "to be prescribed only by a doctor" statement IS required. The following is from the:
"Guidance Document For the Preparation of
Premarket Notification [510(K)] Applications For
Mechanical and Powered Wheelchairs, and
Motorized Three-Wheeled Vehicles"
Provide the following prescription statement (both on the device itself and in the operator's manual, and in any advertising and/or promotional materials) according to 21 CFR 801.109:
Caution: Federal law restricts this device to sale by or on the order of a practitioner licensed by the law of the State in which he/she practices."
And almost all of them use and then are approved for persons that are "restricted to a sitting position." This does not fit many Segway users who use them as a mobility aid but does point up why you should not just have a herd of wheelchairs of unknown safety , maintanence, and cleanliness sitting at the door to be prescribed for use by the Greeter, Guard, Asst Manager, Janitor or whoever is at the door.
Remember that at this point we are talking only about Wheelchair regulations, not Segway regulations. This information is only to point out that when someone is offered a wheelchair (like the recent case where a lawsuit has been filed against a shopping mall. That information has been posted in this section) that the person offering the wheelchair is very likely practicing medcine without a license or doing some other bad thing.
More to come.
Marty