JOW · Sleeve, Limb, Compressible · Chrysalis Intelligence

Device class

Class II

Regulation 870.5800

Total clearances

2020-01-29 → 2026-09-11

Last 12 months

Unique sponsors

Classification details

Medical specialty

Cardiovascular

Review panel

Regulation number

870.5800

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
B&J Manufacturing , Ltd.	4	0	2020-09-19
Ortho8, Inc.	3	0	2022-06-03
Daesung Maref Co., Ltd.	3	0	2021-04-22
Airos Medical, Inc.	3	0	2024-10-11
Manamed, Inc.	3	0	2025-09-17
Koya Medical, Inc.	3	0	2024-01-04
Bio Compression Systems, Inc.	3	2	2026-09-11
Jkh Health Co., Ltd.	2	0	2024-02-23
Jiangsu Synecoun Medical Technology Co., Ltd.	2	0	2021-11-18
Eezcare Medical Corp	2	0	2021-02-11
Tactile Medical	2	1	2026-07-31
Koge Micro Tech Co., Ltd.	1	0	2024-03-06
Vive Health, LLC	1	0	2025-08-08
Sun Scientific, Inc.	1	0	2023-09-07
Wellell, Inc.	1	1	2025-10-28
Medi USA, LP	1	0	2022-07-07
Apex Medical Corp.	1	0	2022-06-28
Huntleigh Healthcare , Ltd.	1	0	2021-09-03
Shenzhen Comen Medical Instruments Co.,Ltd	1	1	2025-12-08
Mego Afek AC , Ltd.	1	0	2022-04-14
Guangzhou Longest Medical Technology Co., Ltd.	1	1	2026-04-24
Slk Medical GmbH	1	0	2020-08-19
Inova Labs	1	0	2020-04-03
Ig Technology, Ltd.	1	0	2023-08-04
Biotab, LLC	1	0	2025-08-18

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
97605	CPT	—	Medium	Sequential pneumatic compression device (limb compression sleeve) service/supply
E0673	HCPCS	Segmental gradient pressure pneumatic appliance, half leg ✓ CMS-verified description	Medium	Compression device sleeve/garment supply code

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-09-11	K261807	Bio Compression Systems, Inc.	Sequential Circulator (SC-4004-DL, SC-4008-DL)
2026-08-31	K254217	Evolym, LLC	Aerloom
2026-07-31	K253555	Tactile Medical	Flexitouch® Plus Advanced Pneumatic Compression System
2026-06-25	K253386	Vistar Medical Supplies Co., Ltd.	DVT Garment
2026-04-24	K250242	Guangzhou Longest Medical Technology Co., Ltd.	Compression Therapy Device (LGT-2202DVT)
2026-02-24	K254267	Mego Afek , Ltd.	NanoPress 760A-BT (760A-BT)
2025-12-12	K250974	Bio Compression Systems, Inc.	Bio Arterial Deluxe (IC-BAP-DX)
2025-12-08	K250190	Shenzhen Comen Medical Instruments Co.,Ltd	Sequential Compression System (SCD600)
2025-10-28	K251466	Wellell, Inc.	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
2025-09-17	K251446	Manamed, LLC	PlasmaFlow X Compression Sleeve Device (XPF0001)
2025-08-18	K251086	Biotab, LLC	PnueAira (PNCU-01)
2025-08-08	K250817	Vive Health, LLC	Coretech Compression System (Coretech RHB3003)
2025-01-15	K241096	Suzhou Minhua Medical Apparatus Supplies Co., Ltd.	Venera 608 Deep Vein Thrombosis (DVT) Prevention System
2024-10-11	K240499	Airos Medical, Inc.	ARTAIRA Arterial Compression Device (AACD01)
2024-10-04	K241746	United Medical Resources, LLC	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
2024-06-25	K232640	Thermabright	Venowave VW5
2024-06-21	K240125	Zenith Technical Innovations	Therm-X (Home); Therm-X (AT)
2024-06-21	K234155	Tactile Medical	Nimbl (model PD08-N1)
2024-03-06	K232270	Koge Micro Tech Co., Ltd.	DVT Motion Pneumatic Compression Device
2024-02-23	K240011	Jkh Health Co., Ltd.	Lymphedema Compression
2024-01-04	K223228	Koya Medical, Inc.	Dayspring
2023-12-22	K232300	Elastimed , Ltd.	ElastiMed SACS
2023-12-14	K231801	Medhealth Medical Limited	MedHealth DVT compression Devices MHH900S/MHH900E
2023-09-07	K222823	Sun Scientific, Inc.	AeroDVx Arm System
2023-08-04	K232006	Ig Technology, Ltd.	LEGACY® IPC