Device Fulfillment Requirements
Medical and wellness devices have specific requirements that standard fulfillment operations miss: serialized units, recall readiness, compliant packaging, and returns that need inspection before restocking. We handle all of these.
Capabilities
- Serial number tracking — each unit tied to an outbound order
- Lot number and manufacturer date tracking on inbound
- Controlled storage — no co-storage with chemicals or food
- Recall support — identify all shipments of affected lot within 24 hours
- Compliant packaging documentation — packing slips, device registration inserts
- Returns inspection — functional check, restock or quarantine per policy
- DSCSA-aware receiving for applicable device categories
Device Categories We Handle
- FDA Class I non-exempt and Class II cleared devices (consult for your specific device)
- Wellness hardware: massagers, TENS units, light therapy devices
- Monitoring devices: blood pressure cuffs, pulse oximeters, thermometers
- Mobility and rehabilitation aids
- OTC diagnostic test kits (non-Rx)
Not Our Category
We do not handle Class III implantable devices, prescription-only devices, drug-device combination products, or biological products. Contact us with your device class and FDA registration status and we'll confirm fit.
Frequently Asked Questions
We are not currently FDA-registered as a device distributor. Many Class I device brands fulfill successfully through non-registered 3PLs under their own FDA registration and distributor agreements. Confirm with your regulatory counsel for your specific device class.
Lot number tracking allows us to generate a complete list of every outbound shipment containing an affected lot — including customer information, order date, and shipping address — within 24 hours of your recall notification.
Yes. We receive returned devices, perform a visual and functional inspection (power-on, obvious damage), grade them, and route them per your warranty policy — return to stock, refurbish queue, or disposal. Full inspection report per unit.
Yes for OTC devices that don't require special Amazon Hazmat approval. We poly-bag, FNSKU label, and bundle per FBA requirements. Restricted categories must be pre-approved by Amazon before we can prep them for FBA.