JOW · Sleeve, Limb, Compressible · Chrysalis Intelligence

Device class

Class II

Regulation 870.5800

Total clearances

2020-01-29 → 2026-07-31

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
Koya Medical, Inc.	3	0	2024-01-04
Daesung Maref Co., Ltd.	3	0	2021-04-22
Airos Medical, Inc.	3	0	2024-10-11
Manamed, Inc.	3	1	2025-09-17
Ortho8, Inc.	3	0	2022-06-03
Tactile Medical	2	1	2026-07-31
Eezcare Medical Corp	2	0	2021-02-11
Bio Compression Systems, Inc.	2	1	2025-12-12
Jiangsu Synecoun Medical Technology Co., Ltd.	2	0	2021-11-18
Jkh Health Co., Ltd.	2	0	2024-02-23
Apex Medical Corp.	1	0	2022-06-28
Elastimed , Ltd.	1	0	2023-12-22
Wellell, Inc.	1	1	2025-10-28
Dalian Labtek Science & Development Co., Ltd.	1	0	2022-02-09
Vena Group, LLC	1	0	2020-07-02
Suzhou Minhua Medical Apparatus Supplies Co., Ltd.	1	0	2025-01-15
Huntleigh Healthcare , Ltd.	1	0	2021-09-03
Renu Medical, Inc.	1	0	2021-05-07
Shenzhen Pango Electronic Co., Ltd.	1	0	2021-11-10
Koge Micro Tech Co., Ltd.	1	0	2024-03-06
Thermabright	1	0	2024-06-25
Medi USA, LP	1	0	2022-07-07
Recovery Force, LLC	1	0	2021-03-21
Shenzhen Comen Medical Instruments Co.,Ltd	1	1	2025-12-08

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
2026-07-31	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
2023-04-03	K230028	Cardinal Health200, LLC	Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly
2023-01-20	K222158	K&L Distributing, Inc.	Capiflo 5001