Lerado

GUDID 06973134780275

LERADO ZHONGSHAN PEACEFUL COVE BUSINESS TRADING Co., Ltd.

Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled

• Primary Device ID: 06973134780275
• NIH Device Record Key: 896701cb-b20e-4214-888d-9aa43b0287b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lerado
• Version Model Number: PW1800
• Company DUNS: 420676175
• Company Name: LERADO ZHONGSHAN PEACEFUL COVE BUSINESS TRADING Co., Ltd.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973134780275 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050087

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: 2023-10-04
• Device Publish Date: 2023-09-26

On-Brand Devices [Lerado]

• 06973134780275: PW1800
• 06973134780237: DR4202
• 06973134780220: RU4022
• 06973134780213: RU4032
• 06973134780183: RU4038
• 06973134780121: MK1000
• 06973134780114: MK2218
• 06973134780107: SB4023
• 06973134780091: SB3023
• 06973134780084: SM3141
• 06973134780060: SM4141
• 06973134780039: DF4110