PSK, Air-bag Type Sequential External Counter-pulsation Device

GUDID 06971379470067

Chongqing PSK-Health Sci-Tech Development Co.,Ltd.

External counterpulsation system, stationary

• Primary Device ID: 06971379470067
• NIH Device Record Key: 631427ab-b0e0-4083-8eda-064bc68c1a88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PSK, Air-bag Type Sequential External Counter-pulsation Device
• Version Model Number: PECP/TI
• Company DUNS: 527142177
• Company Name: Chongqing PSK-Health Sci-Tech Development Co.,Ltd.
• 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: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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	06971379470067 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130439

FDA Product Code

• DRN: Device, Counter-Pulsating, External

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: 2025-04-23
• Device Publish Date: 2025-04-15

On-Brand Devices [PSK, Air-bag Type Sequential External Counter-pulsation Device]

• 06971379470074: PECP/TM
• 06971379470067: PECP/TI