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.