Profile-ESP Bolster

GUDID 00868579000261

The Profile-ESP Bolster device is an optional patient positioning accessory for use within the Profile-ESP workflow of the VMA System. The patient's pelvis is secured while performing the indicated spinal flexion and extension bending. The dimensions are approximately 40-47” wide (adjustable width), 24” deep, 42-58” tall (adjustable height). Weight is approximately 98 lbs. (44 kg).

ORTHO KINEMATICS, INC.

Basic diagnostic x-ray system table, non-powered

• Primary Device ID: 00868579000261
• NIH Device Record Key: 803652db-ebdf-43a3-9b6f-ec67596884d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Profile-ESP Bolster
• Version Model Number: 3.0
• Company DUNS: 932053221
• Company Name: ORTHO KINEMATICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868579000261 [Primary]

FDA Product Code

• INW: Table, 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: 2019-03-11
• Device Publish Date: 2019-02-14

Devices Manufactured by ORTHO KINEMATICS, INC.

• 00868579000216 - VMA DataLink Software: 2019-05-23
• 00868579000223 - VMA DataLink Software: 2019-05-23 VMA DataLink Software (SW4) available to customers on Ortho Kinematics secure site
• 00868579000230 - VMA Image Acquisition Software: 2019-05-23 VMA Image Acquisition Software (SW1) installed on VMA (Motion Normalizer Console)
• 00868579000261 - Profile-ESP Bolster: 2019-03-11The Profile-ESP Bolster device is an optional patient positioning accessory for use within the Profile-ESP workflow of the VMA System. The patient's pelvis is secured while performing the indicated spinal flexion and extension bending. The dimensions are approximately 40-47” wide (adjustable width), 24” deep, 42-58” tall (adjustable height). Weight is approximately 98 lbs. (44 kg).
• 00868579000261 - Profile-ESP Bolster: 2019-03-11 The Profile-ESP Bolster device is an optional patient positioning accessory for use within the Profile-ESP workflow of the VMA S
• 00868579000278 - Profile-ESP Radiographic marker: 2019-03-11 The Profile-ESP Radiographic Marker is an accessory for use within the Profile-ESP workflow of the VMA System. It can facilitate
• 00868579000209 - VMA: 2019-02-21
• 00868579000247 - VMA Motion Normalizer: 2019-02-21 VMA Motion Normalizer (Console, Table, and Upright assemblies)