Is a prescription required for a pulse oximeter?

[DME Daddy]

Pulse oximeters may or may not require a Rx. It is not a decision the DME dealer makes. Before a Pulse ox can be sold in the USA it must be approved for sale by the Food and Drug Administration (FDA). The submitting company can try to get an approval for Over The Counter (OTC) sales. If they receive that approval then no Rx will be required by the seller. For example our host is selling an OTC Pulse Ox and does not require a Rx from buyers. Some submitting companies prefer the stronger Rx required approval for marketing or legal considerations. Some continue to think that if a Rx is required the device is somehow superior. Certainly some Pulse Ox units are very sophisticated but for simple spot checks, the OTC units get the job done nicely.

[Wulfman]

Pulse oximeters may or may not require a Rx. It is not a decision the DME dealer makes. Before a Pulse ox can be sold in the USA it must be approved for sale by the Food and Drug Administration (FDA). The submitting company can try to get an approval for Over The Counter (OTC) sales. If they receive that approval then no Rx will be required by the seller. For example our host is selling an OTC Pulse Ox and does not require a Rx from buyers. Some submitting companies prefer the stronger Rx required approval for marketing or legal considerations. Some continue to think that if a Rx is required the device is somehow superior. Certainly some Pulse Ox units are very sophisticated but for simple spot checks, the OTC units get the job done nicely.

That's not entirely clear, one way or the other. Under the "Specs" tab for that item I linked to in my first post, there is this:

Free Prescription Request System

If a prescription is NOT required, why put that in there?


Den

[WearyOne]

For our host, I compared the page for the pulse ox to the page for a cpap machine---I know the machine needs a script so I wanted to compare how it showed you needed one. For the machine, it clearly states a prescription is needed on the main page for that particular machine where the price is next to the "free shipping" button; the pulse ox does not.

https://www.cpap.com/cpap-machine/respi ... n=HeroShot

https://www.cpap.com/productpage/digita ... lseox.html

And in the section for prescription information in general it doesn't mention pulse ox:

https://www.cpap.com/cpap-faq/Prescriptions.html

"Federal law requires we have a valid prescription on file before we ship your mask, machine and/or humidifier. You do not need a new prescription to fulfill this requirement and can send us your original prescription."



Am I missing something?

[Wulfman]

For our host, I compared the page for the pulse ox to the page for a cpap machine---I know the machine needs a script so I wanted to compare how it showed you needed one. For the machine, it clearly states a prescription is needed on the main page for that particular machine where the price is next to the "free shipping" button; the pulse ox does not.

https://www.cpap.com/cpap-machine/respi ... n=HeroShot

https://www.cpap.com/productpage/digita ... lseox.html

And in the section for prescription information in general it doesn't mention pulse ox:

https://www.cpap.com/cpap-faq/Prescriptions.html

"Federal law requires we have a valid prescription on file before we ship your mask, machine and/or humidifier. You do not need a new prescription to fulfill this requirement and can send us your original prescription."



Am I missing something?

I dunno......
But I DO know that they did require a prescription for this one four to five years ago when I tried to buy one.
From their price list of 10/01/2006:

$385.00 Onyx 9500 Pulse Oximeter


Den

[LoQ]

That's not entirely clear, one way or the other. Under the "Specs" tab for that item I linked to in my first post, there is this:

Free Prescription Request System

If a prescription is NOT required, why put that in there?


Den

It says that on the Specs tab for every item they sell. Do you honestly believe a prescription is required for Pur-Sleep's aromatherapy? For various pillows, some of which aren't even OSA specific? For NeilMed Sinus Rinse, which I bought OVER THE COUNTER at my local drugstore? Here's the context, which makes it seem to me like they are just giving some general benefits of shopping with them:

CPAP.com always offers these services:

8 am to 10 pm CST Toll Free Phone and Email Support
24 hour access to our CPAPtalk.com Support Forum
Learning Center for information on sleep apnea and cpap equipment
Consumer Purchasing Trends Reports
Product Evaluation Results from our Product Challenges
Warranty Services for all items purchased through CPAP.com
Insurance Compliant Invoices
Free Prescription Request System

That is listed on every product.

[Wulfman]

That's not entirely clear, one way or the other. Under the "Specs" tab for that item I linked to in my first post, there is this:

Free Prescription Request System

If a prescription is NOT required, why put that in there?


Den

It says that on the Specs tab for every item they sell. Do you honestly believe a prescription is required for Pur-Sleep's aromatherapy? For various pillows, some of which aren't even OSA specific? For NeilMed Sinus Rinse, which I bought OVER THE COUNTER at my local drugstore? Here's the context, which makes it seem to me like they are just giving some general benefits of shopping with them:

CPAP.com always offers these services:

8 am to 10 pm CST Toll Free Phone and Email Support
24 hour access to our CPAPtalk.com Support Forum
Learning Center for information on sleep apnea and cpap equipment
Consumer Purchasing Trends Reports
Product Evaluation Results from our Product Challenges
Warranty Services for all items purchased through CPAP.com
Insurance Compliant Invoices
Free Prescription Request System

That is listed on every product.

In case you didn't read my first post in this thread (or others over the years), I personally don't believe that ANY of this stuff should require a prescription.

The only things I can see different between the current one available at CPAP.COM and the one years ago is the price and brand. The description in this current one doesn't specify that it's a "sports model". (which were the ones that were previously exempted)


Den

[Slinky]

Pulse oximeters may or may not require a Rx. It is not a decision the DME dealer makes. Before a Pulse ox can be sold in the USA it must be approved for sale by the Food and Drug Administration (FDA). The submitting company can try to get an approval for Over The Counter (OTC) sales. If they receive that approval then no Rx will be required by the seller. For example our host is selling an OTC Pulse Ox and does not require a Rx from buyers. Some submitting companies prefer the stronger Rx required approval for marketing or legal considerations. Some continue to think that if a Rx is required the device is somehow superior. Certainly some Pulse Ox units are very sophisticated but for simple spot checks, the OTC units get the job done nicely.

So would this hold true for the PAP software? For instance Resmed and PR could opt to NOT require that ResScan and EncorePro be sold only "by or on the order of a physician" or they COULD opt to require they be sold only "by or on the order of a physician" as the currently do???

Did PR's SilverLining software have the "by or on the order of a physician" requirement?

[WearyOne]

I just e-mailed cpap.com and asked if their digital finger pulse oximeter requires a prescription. I'll post the answer when it's received.

[WearyOne]

Very quick response from cpap.com regarding whether or not their pulse ox requires a prescription. The e-mail was a bit longer than this and had the name of the cpap.com rep, but I'm just posting the answer...

"Greetings,

No, that does not require a prescription. You may place an order
online or by phone.

https://www.cpap.com/productpage/digita ... lseox.html

Thank you for coming to us with your question! Please check out our
website at:

https://www.cpap.com/

where we have great deals on CPAPs and CPAP-related supplies!"


Pam

[kevincoop]

Thanks everyone for your responses and help. I have gotten my website up and running at http://www.pulseoxstore.com. I have spot check monitors from 37.50 and recording monitors for 84.00. I am trying to keep my prices as low as possible and give the best customer service to build the business up. Hopefully, I will be able to save you a few bucks if you are trying to find an inexpensive pulse ox.
Thanks,
Kevin

[LoQ]

I think prescription is not an issue for the alert systems to be kept in use. The thing that is important is it should work properly. The way these devices are designed are meant for the help of critical patients so that an alert could be maid so that they follow their doctor regularly.

You are a spammer. Hopefully no one is rewarding you by clicking your your spam links so that you are just wasting your time here.