DALTON TACAHE MID-WHEEL DRIVE POWERCHAIR

GUDID 00815027011706

TACAHE MID-WHEEL DRIVE POWERCHAIR, BLUE, WT. LIMIT 350 LBS.

DALTON MEDICAL CORPORATION

Wheelchair, power-assisted, occupant-controlled, collapsible Wheelchair, power-assisted, occupant-controlled, collapsible Wheelchair, power-assisted, occupant-controlled, collapsible Wheelchair, power-assisted, occupant-controlled, collapsible Wheelchair, power-assisted, occupant-controlled, collapsible Wheelchair, power-assisted, occupant-controlled, collapsible Wheelchair, power-assisted, occupant-controlled, collapsible Wheelchair, power-assisted, occupant-controlled, collapsible Wheelchair, power-assisted, occupant-controlled, collapsible Wheelchair, power-assisted, occupant-controlled, collapsible Wheelchair, power-assisted, occupant-controlled, collapsible Wheelchair, power-assisted, occupant-controlled, collapsible Wheelchair, power-assisted, occupant-controlled, collapsible Wheelchair, power-assisted, occupant-controlled, collapsible Wheelchair, power-assisted, occupant-controlled, collapsible Wheelchair, power-assisted, occupant-controlled, collapsible Wheelchair, power-assisted, occupant-controlled, collapsible Wheelchair, power-assisted, occupant-controlled, collapsible

• Primary Device ID: 00815027011706
• NIH Device Record Key: 41ff5664-887f-4601-8dba-a6001a7e4e62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DALTON TACAHE MID-WHEEL DRIVE POWERCHAIR
• Version Model Number: PC1350-BL
• Company DUNS: 874709348
• Company Name: DALTON MEDICAL CORPORATION
• 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: false
• Serial Number: true
• Manufacturing Date: false
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815027011706 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052534

FDA Product Code

• ITI: Wheelchair, Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-10

On-Brand Devices [DALTON TACAHE MID-WHEEL DRIVE POWERCHAIR]

• 00815027011706: TACAHE MID-WHEEL DRIVE POWERCHAIR, BLUE, WT. LIMIT 350 LBS.
• 00815027011690: TACAHE MID-WHEEL DRIVE POWERCHAIR, RED, WT. LIMIT 350 LBS.