510(k) K232300

Device: ElastiMed SACS
Applicant: Elastimed , Ltd.
510(k) number: K232300
Product code: JOW
Decision: Substantially Equivalent (SESE)
Decision date: 2023-12-22
Date received: 2023-08-01
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: Omer Zelka
Address: Hakidma 7 Yokneam Ilit IL 2069236 2069236

FDA Registration Numbers

1423537
2031823
1648700
3016000973
2029275
3007778244
3012446970
3034205725
1721293
3014947294
1526350
3027500264
3033648890
3014694377
3032062344
3003619590
3038295706
3010148613
2028253
3010694026
3005619970
1047843
9616088
3018094310
3014342658
2011171
3034520
8043439
3009247326
1450371
3007420694
1928237
2027046
3010246951
3030517288
1018470
3010256111
2424387
3007141284
3003801933
3011539161
9616933
3012174974
3006792041
3017618673
1921846
3004105270
3033981998
3004116008
9616086
3011554160
1061927
3011200334
3011219270
3011118518
3009155917
1649518
3033511104
3004183730
9680841
3009437400
1061124
9612030
3043226252
3031916218
3005012805
1650907
3012292104
3030441550
1220908
3029871637
3011529836
3029905040
3021767551
3012341425
3010308146
3014144875
3009211636
3017264244
3030063003

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DI	Brand	Company	Published
17290020483079	MyoSleeve	ELASTIMED LTD	2026-01-01
17290020483062	MyoSleeve	ELASTIMED LTD	2026-01-01
17290020483055	MyoSleeve	ELASTIMED LTD	2026-01-01
17290020483048	MyoSleeve	ELASTIMED LTD	2026-01-01
17290020483031	MyoSleeve	ELASTIMED LTD	2026-01-01
17290020483024	MyoSleeve	ELASTIMED LTD	2026-01-01
17290020483017	MyoSleeve	ELASTIMED LTD	2026-01-01
07290020483003	MyoSleeve	ELASTIMED LTD	2025-12-22

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
K232640	Venowave VW5	Thermabright	2024-06-25
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