Kaye Products - S2A

GUDID 00810117142629

Large Tilting Therapy Bench

Kaye Products, Inc.

Core body stabilization/exercise stool

• Primary Device ID: 00810117142629
• NIH Device Record Key: 5eb37a08-7b9b-403a-9969-85347ba5b3d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kaye Products - S2A
• Version Model Number: S2A
• Company DUNS: 082364654
• Company Name: Kaye Products, 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: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810117142629 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K922061

FDA Product Code

• INN: Chair, Adjustable, 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: 2023-07-13
• Device Publish Date: 2023-07-05

Devices Manufactured by Kaye Products, Inc.

• 00810117140007 - Kaye Products, W1/2B: 2023-07-13 Sm Child's Posture Control Walker/Gait Trainer, 2 wheels
• 00810117140014 - Kaye Products - W1/2BR: 2023-07-13 Small Child's Posture Control Walker/Gait Trainer. 4 Wheels
• 00810117140021 - Kaye Products - W1/2BS: 2023-07-13 Small Child's Posture Control Walker/Gait Trainer. 4 Wheels, Front Swivel
• 00810117140076 - Kaye Products - W1/2BRX: 2023-07-13 Small Child's Posture Control Walker /Gait Trainer /4 wheels/Rear Silent
• 00810117140083 - Kaye Products - W1/2BSX: 2023-07-13 Small Child's Posture Control Walker/Gait Trainer /Front Swivel/Rear Silent
• 00810117140090 - Kaye Products - W1B: 2023-07-13 Child's Posture Control Walker/Gait Trainer, 2 Wheels
• 00810117140106 - Kaye Products - W1BR: 2023-07-13 Child's Posture Control Walker/Gait Trainer, 4 Wheels
• 00810117140113 - Kaye Products - W1BS: 2023-07-13 Child's Posture Control Walker/Gait Trainer, 4 Wheels/Front Swivel