Karma 110404000082

GUDID 04719873857104

KARMA MOBILITY COMPANY LIMITED

Push-rim manual wheelchair, non-bariatric

• Primary Device ID: 04719873857104
• NIH Device Record Key: 10639abd-5018-459c-9219-317a6a1b9c93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Karma
• Version Model Number: Flexx
• Catalog Number: 110404000082
• Company DUNS: 671577818
• Company Name: KARMA MOBILITY COMPANY LIMITED
• 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719873857104 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002167

FDA Product Code

• IOR: Wheelchair, Mechanical

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: 2026-03-05
• Device Publish Date: 2026-02-25

On-Brand Devices [Karma]

• 04719873857395: The Flexx Junior is a pediatric manual wheelchair designed to provide mobility, comfort, and pos
• 04719873857104: Flexx
• 04719873856701: KP-40