DALTON PRIMECHAIR

GUDID 00815027011447

PRIMECHAIR POWERCHAIR, RED, WT. LIMIT 300 lbs.

DALTON MEDICAL CORPORATION

Wheelchair, power-assisted, occupant-controlled, collapsible

• Primary Device ID: 00815027011447
• NIH Device Record Key: c5b14ce8-7556-46d4-8f1e-6eb04d106320
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DALTON PRIMECHAIR
• Version Model Number: PC-MP3CM3
• 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	00815027011447 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052496

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: 2016-09-11

On-Brand Devices [DALTON PRIMECHAIR]

• 00815027011744: PRIMECHAIR MID-WHEEL DRIVE, BLUE, WT. LIMIT 300 lbs.
• 00815027011683: PRIMECHAIR, REAR WHEEL DRIVE, BLUE, WT. LIMIT 300 lbs.
• 00815027011676: PRIMECHAIR REAR WHEEL DRIVE, RED, WT. LIMIT 300 lbs.
• 00815027011669: PRIMECHAIR, LIGHTWEIGHT POWERCHAIR, BLUE, WT. LIMIT 250 LBS.
• 00815027011652: PRIMECHAIR, LIGHTWEIGHT POWERCHAIR, RED, WT. LIMIT 250 LBS.
• 00815027011621: PRIMECHAIR MID-WHEEL DRIVE, RED, WT. LIMIT 300 lbs.
• 00815027011447: PRIMECHAIR POWERCHAIR, RED, WT. LIMIT 300 lbs.