SSF403-27-L-1

Organization name

Trulife Inc.

SRN

US-MF-000009657

Manufacturer status

Active

No certificate specifically references this device's Basic UDI-DI.

1 warning recorded — scroll inside the panel to see all entries.

• CW999

  PATIENT USAGE GUIDELINES Warnings and/or contraindications specified for the assembled prosthesis, include, but are not limited to: • Patient must always wear shoes when using the Seattle Skride foot outdoors. • Rinse the Seattle Skride thoroughly with fresh water after any contact with salt water, sand or other contaminates, and dry thoroughly. • Discontinue use and consult your physician or prosthetist if the prosthesis causes pain or injures you in any way. • Never disassemble the Seattle Skride, excluding procedures specifically referred to in the install guide. • Discontinue use and consult your prosthetist if any part of the prosthesis starts to make noise. • Do not attempt to adjust or service the prosthesis except as advised by your prosthetist. • Inform your prosthetist if you lose or gain a significant amount of weight. • Have the prosthesis serviced at regular intervals specified by the prosthetist. • Trulife’s prosthetic feet are manufactured and tested for a particular weight and activity level. Use by an amputee, other than the one for whom it was originally manufactured, may be dangerous and will void any written or implied warranty.

Primary placement in Germany; available across 13 countries total.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Y062409TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)

• Class I medical devices in EUDAMED