Top 10 Medical Devices That Require a Prescription for Online Sales

Not every medical product sold online requires a prescription, but many of the most popular durable medical equipment (DME) categories do. If you are building or running an online medical device store, knowing which products require prescription verification is essential for compliance.

Here are the top 10 prescription-required medical devices commonly sold through ecommerce.

1. CPAP and BiPAP Machines

Continuous Positive Airway Pressure (CPAP) and Bilevel Positive Airway Pressure (BiPAP) machines are the most commonly sold prescription medical devices online. Used to treat obstructive sleep apnea, these Class II devices always require a valid prescription. Note that CPAP accessories like masks, tubing, and filters generally do not require prescriptions when sold as replacement parts.

2. Oxygen Concentrators

Both portable and stationary oxygen concentrators are prescription-required devices. They deliver supplemental oxygen to patients with chronic respiratory conditions like COPD. The FDA requires a prescription specifying the oxygen flow rate and hours of daily use. The COVID-19 pandemic saw a surge in demand for these devices, and FDA issued specific guidance about online sales compliance.

3. Power Wheelchairs

Power wheelchairs and complex rehab technology (CRT) require prescriptions. Medicare and Medicaid also require a face-to-face examination and a detailed written order. Online retailers selling power wheelchairs need to verify not just the prescription but often additional documentation like a Certificate of Medical Necessity (CMN).

4. Nebulizers

Nebulizers convert liquid medication into a mist that patients inhale to treat asthma, COPD, and other respiratory conditions. The nebulizer device itself is a prescription item, and the medications used with it (such as albuterol) also require separate prescriptions.

5. Continuous Glucose Monitors (CGMs)

Devices like the Dexcom G7 and Abbott FreeStyle Libre are prescription-required. They continuously track blood glucose levels for diabetic patients. The prescription must specify the specific CGM system and typically includes the sensors and transmitters in addition to the receiver or reader device.

6. Insulin Pumps

Insulin pumps and their associated supplies (infusion sets, reservoirs) are prescription-required Class II devices. They deliver precise insulin doses to diabetic patients throughout the day. Given the critical nature of insulin dosing, prescription verification for these devices is especially important.

7. Hospital Beds (Powered/Adjustable)

While basic manual hospital beds may not require prescriptions, powered and semi-electric hospital beds used in home care settings do require a prescription or medical order. Medicare requires a CMN for coverage, and the prescription must specify the medical necessity for a powered bed.

8. TENS Units (Prescription-Grade)

Transcutaneous Electrical Nerve Stimulation (TENS) units exist in both over-the-counter and prescription versions. Prescription-grade TENS units offer higher power output and more sophisticated programming. The distinction between OTC and prescription TENS units has been a source of confusion, so retailers should carefully classify their products.

9. Suction Machines

Medical suction machines (aspirators) used to clear airways of mucus or other secretions are prescription devices. They are commonly used by patients with tracheostomies, dysphagia, or other conditions that impair airway clearance. Both portable and stationary models require prescriptions.

10. Patient Lifts (Powered)

Powered patient lifts used in home care settings to transfer patients between beds, wheelchairs, and other surfaces require prescriptions. Manual hydraulic lifts may not require prescriptions in all jurisdictions, but powered ceiling lifts and floor lifts typically do.

How to Determine If Your Products Require Prescriptions

If you are unsure whether a specific product requires a prescription, check these resources:

• FDA Product Classification Database — search by product name or product code to see the device classification and whether it is prescription-restricted
• Device labeling — look for the "Rx only" or "Caution: Federal law restricts this device to sale by or on the order of a licensed practitioner" statement
• Manufacturer guidance — contact the device manufacturer for their compliance requirements
• Legal counsel — when in doubt, consult with a healthcare regulatory attorney

Compliance Made Simple

If you sell any of these devices online, you need a prescription verification system. RxCompliant works with all of these product categories, using AI to validate prescriptions and NPI numbers in seconds. Start your free account and protect your store with compliant prescription verification.