Karma 110400000021

GUDID 04719873857395

The Flexx Junior is a pediatric manual wheelchair designed to provide mobility, comfort, and postural support for children with mobility limitations. Available in self-propelled (Model FLX-J00 with fixed backrest, Model FLX-J50 with foldable backrest) and transit configurations, it is primarily intended for indoor use with limited outdoor capability on smooth surfaces. The wheelchair offers both self-propulsion with 20" or 22" quick-release rear wheels and transit propulsion with 14" quick-release rear wheels. The device supports users weighing up to (165 lbs) 75 kg and is engineered for growth and incorporates adjustable features to accommodate growth.

KARMA MOBILITY COMPANY LIMITED

Push-rim manual wheelchair, non-bariatric

• Primary Device ID: 04719873857395
• NIH Device Record Key: c57220ff-dc08-4cc1-812a-b314417a3cda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Karma
• Version Model Number: Flexx Junior
• Catalog Number: 110400000021
• 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	04719873857395 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250576

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