Draft. This document is awaiting review by counsel and is not yet in effect. Highlighted items are still to be confirmed.

Product and regulatory notice

Allied Medical Management LLC · alliedmedical.supplies

Effective date: [effective date]

This notice applies to products offered by Allied Medical Management LLC ("Allied," "we," "us," or "our") through https://alliedmedical.supplies (the "site"). Read it together with our Terms of use, Terms of sale, and Privacy policy. If this notice and the Terms of sale conflict on a matter that concerns an order, the Terms of sale control.

Sales to licensed businesses only

Allied is a wholesaler. We sell durable medical equipment (DME) and related supplies only to businesses with an Allied trade account, such as DME suppliers, pharmacies, clinics and physical therapy practices, med-spas, and distributors.

  • A resale certificate is required to open a trade account.
  • We do not sell to patients or consumers. If you are a patient, please speak with your healthcare provider or a supplier that serves patients.
  • We may ask for proof of your business status and of any license or permit your state requires for the products you order. We may decline a quote request or order, or cancel an order, if we cannot confirm that you are eligible to buy the product.

Product information is not medical advice

Product descriptions, specifications, images, and other content on the site are written for professional buyers making purchasing decisions. They are not medical advice. They do not replace a product's labeling, its instructions for use (IFU), or the judgment of a licensed healthcare professional.

  • Site content is not a promise of any clinical result for any patient. For what a product is intended to do, rely on its labeling and IFU.
  • Do not rely on the site to decide whether a product is right for a particular patient.
  • Nothing on the site is insurance coverage, billing code, or reimbursement advice.

FDA-regulated medical devices

Some products in our catalog are medical devices regulated by the US Food and Drug Administration (FDA). Depending on the product, a device may be in Class I or Class II, and it may be exempt from, or subject to, FDA premarket notification (510(k)).

  • Some devices are prescription devices. Their labeling bears the symbol "Rx only" or a statement that federal law restricts the device to sale by or on the order of a licensed practitioner.
  • Before we ship a prescription device, we may require proof that you are lawfully permitted to buy and hold it. You are responsible for confirming that you may lawfully buy it. You may sell, dispense, or use a prescription device only as its labeling and federal and state law allow, which generally means on the order of a licensed practitioner.
  • If you need regulatory information for a specific product, such as its device class or FDA clearance, contact us. We will share the information we have, including information supplied by the manufacturer.

AMD compression systems

AMD ("Allied Medical Devices") is Allied's own brand. AMD products are made for Allied by third-party manufacturers and sold under the AMD brand.

  • The AMD sequential (pneumatic) compression systems, 12-chamber and 8-chamber, are medical devices regulated by FDA. They have been cleared by FDA under premarket notification (510(k)).*
  • FDA clearance under 510(k) is not FDA approval. It does not mean that FDA approves or endorses the device, Allied, or this site.
  • Each system's indications for use are only those stated in its FDA-cleared labeling and IFU. Nothing on the site is meant to state, expand, or change those indications. If anything on the site differs from the labeling or IFU, follow the labeling and IFU.
  • Sell, dispense, and use each system only in line with its cleared labeling and IFU. Do not promote it to your customers for any use that its cleared labeling does not include.
  • Contact us for a copy of the current labeling and IFU.

* 510(k) numbers for AMD systems are available to trade account holders on request.

Your responsibilities as a buyer

You are responsible for your own compliance with the federal, state, and local laws and rules that apply to your business. This includes the following.

  • Follow each product's labeling and IFU, including its warnings, contraindications, and any prescription restriction.
  • Hold and keep current every license, permit, accreditation, or registration required to buy, sell, rent, or dispense DME or medical devices where you do business, and follow your state's DME rules.
  • Meet all prescription and documentation requirements before you dispense a prescription device.
  • Store and handle products as their labeling directs.
  • Keep the manufacturer's labeling and IFU with each product you resell or dispense. Do not remove, cover, or alter product labels or markings.
  • Make sure your own advertising, product listings, and statements to customers are truthful, supported by evidence, and consistent with the product's labeling.
  • Give any warnings that the law requires of you as a seller, including California Proposition 65 warnings, as described below.
  • We offer products for sale in the United States. If you export a product, you are responsible for meeting US export rules and the rules of the destination country.

California Proposition 65

California's Proposition 65 requires businesses with 10 or more employees to give a clear and reasonable warning before they knowingly and intentionally expose anyone in California to a chemical that the state lists as causing cancer, birth defects, or other reproductive harm. Some products in our catalog may contain listed chemicals.

  • Where the law makes Allied responsible for a Proposition 65 warning for a product, we will provide it on the product or its labeling, or by written notice to the buyer, as the regulations allow.
  • If you sell or distribute products to persons in California, including through a website or catalog, you are responsible for the warnings the law requires of you as a seller. This includes posting or passing on warning materials you receive from us or from a manufacturer.
  • Contact us if you need the warning information we have for a specific product.
  • This general notice is not a product-specific Proposition 65 warning.

Reporting adverse events and complaints

If you learn of a death, serious injury, malfunction, or other adverse event involving a product bought from Allied, or you have a complaint about a product's quality, labeling, or performance, report it to us promptly.

This process is not for medical emergencies. If someone needs urgent medical help, call 911.

Please include the product name, SKU or model, lot or serial number, your order number, the date of the event, and a description of what happened. Do not include a patient's name, contact details, or other information that identifies a patient, and do not send patient information through the site's quote request form. If we need more detail, we will contact you.

We may forward your report to the product's manufacturer, and to FDA where the law requires. You may also report a problem with a medical device directly to FDA through MedWatch, the FDA Safety Information and Adverse Event Reporting Program.

Some facilities, such as hospitals, ambulatory surgical facilities, nursing homes, and outpatient diagnostic or treatment facilities other than physicians' offices, are "device user facilities" under FDA's medical device reporting rules (21 CFR Part 803). These facilities have their own mandatory reporting duties. Reporting to Allied does not satisfy those duties.

Recalls and safety notices

  • If a recall, correction, or removal affects a product Allied sold you, whether it is started by the manufacturer, by Allied, or at FDA's request or order, we will make reasonable efforts to notify affected customers using the contact details in our records. Keep your account contact details current.
  • Keep records that let you trace each product, by lot or serial number where available, to the customers or locations you supplied. You may need them to carry out recall instructions.
  • Follow the recall instructions you receive from Allied, the manufacturer, or FDA, including instructions to stop selling, set aside, or return affected stock.
  • If you learn of a recall or safety notice for a product you bought from us before we contact you, please tell us.

Product images and specifications

  • Product images and diagrams are for identification only. Some are illustrations, not photographs of the product.
  • Manufacturers may change a product's design, materials, color, packaging, or specifications without notice. The product you receive may differ from the images or specifications on the site.
  • The labeling and IFU that ship with the product take priority over anything on the site.
  • If a specification matters to your purchase, ask us to confirm it in writing before you order. A quote is not binding until Allied confirms your order in writing. See our Terms of sale.
  • Warranty terms, and the limits on them, are in our Terms of sale. This notice does not add to or change them.
  • We may correct errors in product information at any time.

Trademarks

  • AMD, Allied Medical Devices, and the AMD logo are brand names and marks used by Allied.
  • You may use the AMD name to accurately identify genuine AMD products that you resell. Do not use our marks in a way that suggests you are Allied or that Allied sponsors or endorses you. Do not use them in your business name, domain name, or product names, and do not use the AMD logo in your own marketing other than as it appears on the product and its packaging, without our written permission.
  • Other product names, brand names, and logos on the site belong to their owners. We use them only to identify products. Their use does not mean that the owner is affiliated with, sponsors, or endorses Allied.

Changes to this notice

We may update this notice. When we do, we will post the new version on this page and change the effective date above.

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