510(k) K232640

Device: Venowave VW5
Applicant: Thermabright
510(k) number: K232640
Product code: JOW
Decision: Substantially Equivalent (SESE)
Decision date: 2024-06-25
Date received: 2023-08-25
Regulation: 870.5800
Classification name: Sleeve, Limb, Compressible
Medical specialty: Cardiovascular
Review panel: Cardiovascular
Device class: 2
Clearance type: Special
Statement or summary: Summary
Third party reviewed: N

Related Records

Applicant Contact

Contact: Liane Parker
Address: 4035 Cinwood St. NW Massillon OH US 44646 44646

FDA Registration Numbers

3010190204
8043439
3012651177
3034205725
1061124
3010256111
3009350690
3004727093
3004183730
3007518069
3007420694
3012292104
3040278145
3012446970
1450371
3010246951
3009247326
1018470
3020163307
3014344059
1000589001
3011024991
3027977504
3008902816
3011118518
3009437400
8022590
3017264244
3005012805
3033511104
3013557562
3029923680
1423537
3005157379
2424387
3023215120
3018269548
3014947294
3016000973
9611425
3012174974
3012341425
3014491159
3015536408
3009176340
3021767551
1648700
3011529836
3013528589
3009155917
3017618673
2028253
3005619970
1649518
3032062344
3030153385
3038295706
3008773774
1063312
3011191255
3014579161
3034520
1417592
1928237
1061927
3031916218
3003619590
3010308146
3007699082
3004105270
3014834638
3011767724
3024685280
3012494290
1921846
3011539161
3011219270
3033981998
3029871637
8043817
3016761372
1526350
3006339858
3006792041
1047843
3030517288
3010148613
1650907
3004116008
3014144875
3013659199
3029905040
9616088
3010694026
3011554160
2029275
3003801933
3000143502
3007778244
9680841
2031823
2183650
3027500264
3030441550
9612030
3007141284
3007573469
9616086
3020703724
3032391
9616933
1220908
3033648890
3043226252
3009211636
1721293
3014542717
3011149139
3011200334
3030063003
1834003
2011171
2027046
3018094310
3014694377
3014342658

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DI	Brand	Company	Published
00627843553601	Venowave VW5	Therma Bright Inc	2024-10-17

Other 510(k) Records For Product Code JOW

510(k)	Device	Applicant	Decision date
K250242	Compression Therapy Device (LGT-2202DVT)	Guangzhou Longest Medical Technology Co., Ltd.	2026-04-24
K254267	NanoPress 760A-BT (760A-BT)	Mego Afek , Ltd.	2026-02-24
K250974	Bio Arterial Deluxe (IC-BAP-DX)	Bio Compression Systems, Inc.	2025-12-12
K250190	Sequential Compression System (SCD600)	Shenzhen Comen Medical Instruments Co.,Ltd	2025-12-08
K251466	VenAir, 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 Compr	Wellell, Inc.	2025-10-28
K251446	PlasmaFlow X Compression Sleeve Device (XPF0001)	Manamed, LLC	2025-09-17
K251086	PnueAira (PNCU-01)	Biotab, LLC	2025-08-18
K250817	Coretech Compression System (Coretech RHB3003)	Vive Health, LLC	2025-08-08
K241096	Venera 608 Deep Vein Thrombosis (DVT) Prevention System	Suzhou Minhua Medical Apparatus Supplies Co., Ltd.	2025-01-15
K240499	ARTAIRA Arterial Compression Device (AACD01)	Airos Medical, Inc.	2024-10-11
K241746	UMED 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 CUFF	United Medical Resources, LLC	2024-10-04
K234155	Nimbl (model PD08-N1)	Tactile Medical	2024-06-21
K240125	Therm-X (Home); Therm-X (AT)	Zenith Technical Innovations	2024-06-21
K232270	DVT Motion Pneumatic Compression Device	Koge Micro Tech Co., Ltd.	2024-03-06
K240011	Lymphedema Compression	Jkh Health Co., Ltd.	2024-02-23