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

FDA UDI

Class II (US FDA UDI)

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

Identity

Trade Name: PSK, Air-bag Type Sequential External Counter-pulsation Device FDA UDI
Generic Name: External counterpulsation system, stationary FDA UDI
Model / Reference: PECP/TI FDA UDI

Identifiers

Primary DI / UDI-DI: 06971379470067 FDA UDI
510(k) Number: K130439 FDA UDI
FDA Product Code: DRN FDA UDI
GMDN Term: External counterpulsation system, stationary FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.5225 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: External counterpulsation system, stationary

PSK, Air-bag Type Sequential External Counter-pulsation Device by Chongqing PSK-Health Sci-Tech Development Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID

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Cleared under the same submission

K130439 also covers:

PSK, Air-bag Type Sequential External Counter-pulsation Device — Chongqing PSK-Health Sci-Tech Development Co., Ltd.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

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

Sources (1)

FDA UDI 631427ab-b0e0-4083-8eda-064bc68c1a88 33 fields · synced May 30, 2026