FDA.report

510(k) K232270

Device
DVT Motion Pneumatic Compression Device
Applicant
Koge Micro Tech Co., Ltd.
510(k) number
K232270
Product code
JOW
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-06
Date received
2023-07-31
Regulation
870.5800
Classification name
Sleeve, Limb, Compressible
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Doris Chiu
Address
5f., # 6, Jiankang Rd. 1, Zhonghe Dist. New Taipei TW 23586 23586

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code JOW

510(k)DeviceApplicantDecision date
K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd.2026-04-24
K254267NanoPress 760A-BT (760A-BT)Mego Afek , Ltd.2026-02-24
K250974Bio Arterial Deluxe (IC-BAP-DX)Bio Compression Systems, Inc.2025-12-12
K250190Sequential Compression System (SCD600)Shenzhen Comen Medical Instruments Co.,Ltd2025-12-08
K251466VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential ComprWellell, Inc.2025-10-28
K251446PlasmaFlow X Compression Sleeve Device (XPF0001)Manamed, LLC2025-09-17
K251086PnueAira (PNCU-01)Biotab, LLC2025-08-18
K250817Coretech Compression System (Coretech RHB3003)Vive Health, LLC2025-08-08
K241096Venera 608 Deep Vein Thrombosis (DVT) Prevention SystemSuzhou Minhua Medical Apparatus Supplies Co., Ltd.2025-01-15
K240499ARTAIRA Arterial Compression Device (AACD01)Airos Medical, Inc.2024-10-11
K241746UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF; UMED REPROCESSED KENDALL SCD EXPRESS SLEEVE; UMED REPROCESSED AIRCAST ELITE CALF CUFF 3040 3050; UMED REPROCESSED CTC VP 501 CALF CUFF; UMED REPROCESSED CTC VP 520 FOOT CUFFUnited Medical Resources, LLC2024-10-04
K232640Venowave VW5Thermabright2024-06-25
K234155Nimbl (model PD08-N1)Tactile Medical2024-06-21
K240125Therm-X (Home); Therm-X (AT)Zenith Technical Innovations2024-06-21
K240011Lymphedema CompressionJkh Health Co., Ltd.2024-02-23