Astrotilt 98

GUDID B829981

PDG Product Design Group Inc

Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric

• Primary Device ID: B829981
• NIH Device Record Key: 70651545-ba4d-4a8c-bdf3-aac7659305d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Astrotilt
• Version Model Number: Astrotilt
• Catalog Number: 98
• Company DUNS: 253873905
• Company Name: PDG Product Design Group Inc
• 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: 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
HIBCC	B829981 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061475

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: 2023-06-15
• Device Publish Date: 2023-06-07

Devices Manufactured by PDG Product Design Group Inc

• B829971 - Luna: 2023-06-15
• B829981 - Astrotilt: 2023-06-15
• B829981 - Astrotilt: 2023-06-15
• B829991 - Eclipse 350: 2023-06-15
• B829271 - Bentley Manual Tilt Wheelchair: 2022-09-09
• B829101 - Bentley Manual Tilt Wheelchair: 2020-10-06
• B829111 - Eclipse Bariatric Manual Wheelchair: 2020-10-06
• B829121 - Stellar Manual Tilt Wheelchair: 2020-10-06
• B829151 - Fuze Manual Tilt Wheelchair: 2020-10-06