Hi-Fortune

GUDID 06973852594581

The device is a motor-driven, and indoor transportation vehicle with the intended use to provide mobility to a disabled or an elderly person limited to a seated position.

Kunshan Hi-Fortune Health Products Co.,Ltd

Multi-terrain sports wheelchair, electric-motor-driven Multi-terrain sports wheelchair, electric-motor-driven Multi-terrain sports wheelchair, electric-motor-driven Multi-terrain sports wheelchair, electric-motor-driven Multi-terrain sports wheelchair, electric-motor-driven Multi-terrain sports wheelchair, electric-motor-driven

• Primary Device ID: 06973852594581
• NIH Device Record Key: 95127a76-f33a-4c3c-8935-da531375ba33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hi-Fortune
• Version Model Number: P16H
• Company DUNS: 548310008
• Company Name: Kunshan Hi-Fortune Health Products Co.,Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973852594581 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212503

FDA Product Code

• ITI: Wheelchair, Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-01
• Device Publish Date: 2022-05-24

On-Brand Devices [Hi-Fortune]

• 06973852590095: Weight: 43kg, L 1165mm*W640mm*H320mm
• 06973852590088: Weight: 45kg, L1165mm*W640mm*H320mm
• 06973852590071: Weight: 47kg, L1370mm*W720mm*H360mm
• 06973852590064: Weight: 7.8kg, L570mm*W390mm*H985mm
• 06973852590057: Weight: 39kg, L820mm*W720mm*H550mm
• 06973852590040: Weight: 10.5kg, L745mm*W325mm*H760mm
• 06973852590033: Weight: 10.5kg, L770mm*W325mm*H760mm
• 06973852591085: Weight: 26.6kg, L1005mm*615mm*1270mm HY108 are versatile mobile lifts intended mainly for us
• 06973852596035: Dimensions: 900*676*870, Product net weight: 45 Kg.
• 06973852594581: The device is a motor-driven, and indoor transportation vehicle with the intended use to provide