Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2424387

FEI Number

2424387

Entity Name

BIO COMPRESSION SYSTEMS, INC.

City/State/Country

MOONACHIE, NJ, US

Establishment Address

120 WEST COMMERCIAL AVE., MOONACHIE, NJ 07074, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Bio Compression Systems, Inc (Owner Number: 2424387)

Owner / Operator Contact Address

120 West Commercial Ave, --, Moonachie, NJ 07074, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K122112

PMA Number

N/A

All Registered Proprietary Names

IC-BAP-DL BioArterial Plus, Arterial Blood Flow Enhancement System IC-BAP-DL-230 Bio Arterial Plus, Arterial Blood Flow Enhancement System APGN-3045-FC Arterial Foot & Calf Sleeve - Narrow APGW-3045-FC Arterial Foot & Calf Sleeve - Wide APG-3045-FC Arterial Foot & Calf Sleeve - Standard APG-3035-FA Arterial Full Arm Sleeve G8-3035-SH-L-L 8-Chamber Arm & Shoulder Sleeve - Large Left GS-3045-H 4-Chamber Leg Sleeve - Half GBA-3045-S-L Bio Abdominal - Small Left leg GA-3045-H 4-Chamber Adjustable Leg Sleeve - Half GV-3010-L-R Elite 8 Bio Vest - Large Right GS-3035-SH/L 4-Chamber Arm & Shoulder Sleeve - Large GN-3045-M 4-Chamber Leg Sleeve - Medium Narrow A8-3045-S 8-Chamber Leg Sleeve - Small Adjustable GS-3035-S 4-Chamber Arm Sleeve - Small GWA8-3045-M 8-Chamber Leg Sleeve - Wide Adjustable Medium GBA-3045-M-R Bio Abdominal - Medium Right leg GWA-3045-M 4-Chamber Leg Sleeve - Wide Adjustable Medium GBA-3045-L-R Bio Abdominal - Large Right leg GW-3045-L 4-Chamber Leg Sleeve - Large G8-3035-SH-S-R 8-Chamber Arm & Shoulder Sleeve - Small Right A8-3045-M 8-Chamber Leg Sleeve - Medium Adjustable GS-3035-SH/M 4-Chamber Arm & Shoulder Sleeve - Medium G8-3045-L 8-Chamber Leg Sleeve - Large G8-3035-L 8-Chamber Arm Sleeve - Large GV-3010-S-R Elite 8 Bio Vest - Small Right GXW8-3045 8-Chamber Leg Sleeve - Extra Wide GW8-3045-L 8-Chamber Leg Sleeve - Large Wide GWA8-3045-S 8-Chamber Leg Sleeve - Wide Adjustable Small GS-3035-SH-S-L 4-Chamber Arm & Shoulder Sleeve - Small Left GS-3035-L 4-Chamber Arm Sleeve - Large G8-3035-SH-M-R 8-Chamber Arm & Shoulder Sleeve - Medium Right GV-3010-L-2 Elite 8 Vest with Bilateral Arms - Large GV-3010-M-R Elite 8 Bio Vest - Medium Right GS-3035-M 4-Chamber Arm Sleeve - Medium GWA-3045-L 4-Chamber Leg Sleeve - Wide Adjustable Large GV-3010-L-L Elite 8 Bio Vest - Large Left GS-3035-SH-M-R 4-Chamber Arm & Shoulder Sleeve - Medium Right G8-3035-S 8-Chamber Arm Sleeve - Small GN8-3045-L 8-Chamber Leg Sleeve - Large Narrow G8-3045-M 8-Chamber Leg Sleeve - Medium GBA-3045-L-2 Bio Pants - Large GV-3010-M-L Elite 8 Bio Vest - Medium Left G8-3035-SH-S-L 8-Chamber Arm & Shoulder Sleeve - Small Left GBA-3045-L-L Bio Abdominal - Large Left leg GS-3045-L 4-Chamber Leg Sleeve - Large G8-3035-SH/S 8-Chamber Arm & Shoulder Sleeve - Small GW8-3045-M 8-Chamber Leg Sleeve - Medium Wide GWA8-3045-L 8-Chamber Leg Sleeve - Wide Adjustable Large GN-3045-L 4-Chamber Leg Sleeve - Large Narrow GA-3045-M 4-Chamber Adjustable Leg Sleeve - Medium SC-2008-OC-230 Sequential Circulator G8-3035-SH-L-R 8-Chamber Arm & Shoulder Sleeve - Large Right GBA-3045-M-2 Bio Pants - Medium GN8-3045-M 8-Chamber Leg Sleeve - Medium Narrow GA-3045-L 4-Chamber Adjustable Leg Sleeve - Large SC-2004-OC Sequential Circulator GXWA-3045 4-Chamber Leg Sleeve - Extra Wide Adjustable G8-3035-SH/M 8-Chamber Arm & Shoulder Sleeve - Medium GXW-3045 4-Chamber Leg Sleeve - Extra Wide A8-3045-L 8-Chamber Leg Sleeve - Large Adjustable SC-2008-OC Sequential Circulator GW8-3045-S 8-Chamber Leg Sleeve - Small Wide GN-3045-S 4-Chamber Leg Sleeve - Small Narrow GS-3035-SH-L-R 4-Chamber Arm & Shoulder Sleeve - Large Right GXWA8-3045 8-Chamber Leg Sleeve - Extra Wide Adjustable GBA-3045-S-R Bio Abdominal - Small Right leg GN8-3045-S 8-Chamber Leg Sleeve - Small Narrow GBA-3045-S-2 Bio Pants - Small GV-3000-8C 8-Chamber Vest GBA-3045-M-L Bio Abdominal - Medium Left leg GS-3045-S 4-Chamber Leg Sleeve - Small GV-3000 4-Chamber Vest GW-3045-H 4-Chamber Leg Sleeve - Half Wide GV-3010-S-L Elite 8 Bio Vest - Small Left GW-3045-M 4-Chamber Leg Sleeve - Medium G8-3035-SH/L 8-Chamber Arm & Shoulder Sleeve - Large GS-3045-M 4-Chamber Leg Sleeve - Medium G8-3035-M 8-Chamber Arm Sleeve - Medium GWA-3045-S 4-Chamber Leg Sleeve - Wide Adjustable Small GS-3035-SH/S 4-Chamber Arm & Shoulder Sleeve - Small GWA-3045-H 4-Chamber Leg Sleeve - Wide Adjustable Half G8-3035-SH-M-L 8-Chamber Arm & Shoulder Sleeve - Medium Left G8-3045-S 8-Chamber Leg Sleeve - Small GS-3035-SH-L-L 4-Chamber Arm & Shoulder Sleeve - Large Left GV-3010-S-2 Elite 8 Vest with Bilateral Arms - Small GA-3045-S 4-Chamber Adjustable Leg Sleeve - Small GS-3035-SH-S-R 4-Chamber Arm & Shoulder Sleeve - Small Right GW-3045-S 4-Chamber Leg Sleeve - Small GS-3035-SH-M-L 4-Chamber Arm & Shoulder Sleeve - Medium Left SC-2004-OC-230 Sequential Circulator GV-3010-M-2 Elite 8 Vest with Bilateral Arms - Medium GWA-3045-H 4-Chamber Leg Sleeve - Wide Adjustable Half GS-3045-L 4-Chamber Leg Sleeve - Large GXWA-3045 4-Chamber Leg Sleeve - Extra Wide Adjustable GN-3045-M 4-Chamber Leg Sleeve - Medium Narrow GS-3035-SH-L-L 4-Chamber Arm & Shoulder Sleeve - Large Left GXW-3045 4-Chamber Leg Sleeve - Extra Wide GS-3045-S 4-Chamber Leg Sleeve - Small GN-3045-S 4-Chamber Leg Sleeve - Small Narrow GW-3045-S 4-Chamber Leg Sleeve - Small GV-3000 4-Chamber Vest GS-3035-SH-S-R 4-Chamber Arm & Shoulder Sleeve - Small Right GS-3035-L 4-Chamber Arm Sleeve - Large GS-3035-M 4-Chamber Arm Sleeve - Medium GA-3045-H 4-Chamber Adjustable Leg Sleeve - Half SC-2004FC-OC Sequential Circulator GA-3045-M 4-Chamber Adjustable Leg Sleeve - Medium GW-3045-M 4-Chamber Leg Sleeve - Medium GW-3045-H 4-Chamber Leg Sleeve - Half Wide GN-3045-L 4-Chamber Leg Sleeve - Large Narrow GS-3035-SH/S 4-Chamber Arm & Shoulder Sleeve - Small GWA-3045-S 4-Chamber Leg Sleeve - Wide Adjustable Small GS-3035-SH/L 4-Chamber Arm & Shoulder Sleeve - Large GS-3035-SH/M 4-Chamber Arm & Shoulder Sleeve - Medium GS-3045-M 4-Chamber Leg Sleeve - Medium GS-3045-H 4-Chamber Leg Sleeve - Half GWA-3045-M 4-Chamber Leg Sleeve - Wide Adjustable Medium GA-3045-S 4-Chamber Adjustable Leg Sleeve - Small GS-3035-S 4-Chamber Arm Sleeve - Small GS-3035-SH-M-L 4-Chamber Arm & Shoulder Sleeve - Medium Left GWA-3045-L 4-Chamber Leg Sleeve - Wide Adjustable Large GS-3035-SH-L-R 4-Chamber Arm & Shoulder Sleeve - Large Right GA-3045-L 4-Chamber Adjustable Leg Sleeve - Large GW-3045-L 4-Chamber Leg Sleeve - Large GS-3035-SH-M-R 4-Chamber Arm & Shoulder Sleeve - Medium Right GS-3035-SH-S-L 4-Chamber Arm & Shoulder Sleeve - Small Left A8-3045-S 8-Chamber Leg Sleeve - Small Adjustable GW-3045-M 4-Chamber Leg Sleeve - Medium GS-3035-M 4-Chamber Arm Sleeve - Medium GXW8-3045-BT G8-3035-L 8-Chamber Arm Sleeve - Large GBA-3045-M-2 Bio Pants - Medium GN8-3045-M-BT SC-2008-DL Sequential Circulator GN8-3045-L 8-Chamber Leg Sleeve - Large Narrow GXWA8-3045 8-Chamber Leg Sleeve - Extra Wide Adjustable GW-3045-M-BT GS-3035-SH-S-L 4-Chamber Arm & Shoulder Sleeve - Small Left GS-3035-SH-M-R-BT GV-3000-8C 8-Chamber Vest GS-3035-SH-M-L 4-Chamber Arm & Shoulder Sleeve - Medium Left G8-3035-S 8-Chamber Arm Sleeve - Small GS-3035-S 4-Chamber Arm Sleeve - Small G8-3035-SH-S-R 8-Chamber Arm & Shoulder Sleeve - Small Right G8-3045-M-BT GV-3010-M-2 Elite 8 Vest with Bilateral Arms - Medium GS-3045-L 4-Chamber Leg Sleeve - Large G8-3035-SH-M-L 8-Chamber Arm & Shoulder Sleeve - Medium Left G8-3045-S-BT GBA-3045-M-R Bio Abdominal - Medium Right leg GW-3045-L-BT GS-3045-S 4-Chamber Leg Sleeve - Small GN8-3045-L-BT GW8-3045-L-BT GV-3010-M-L-BT G8-3035-SH-M-R-BT GW8-3045-L 8-Chamber Leg Sleeve - Large Wide G8-3035-SH-S-L 8-Chamber Arm & Shoulder Sleeve - Small Left G8-3035-SH-M-R 8-Chamber Arm & Shoulder Sleeve - Medium Right GS-3035-SH-M-R 4-Chamber Arm & Shoulder Sleeve - Medium Right A8-3045-L 8-Chamber Leg Sleeve - Large Adjustable GV-3010-L-2 Elite 8 Vest with Bilateral Arms - Large GN8-3045-S 8-Chamber Leg Sleeve - Small Narrow G8-3045-S 8-Chamber Leg Sleeve - Small GW8-3045-M 8-Chamber Leg Sleeve - Medium Wide SC-4008-DL Sequential Circulator SC-2004-DL-BT BioTab Sequential Circulator GA-3045-H 4-Chamber Adjustable Leg Sleeve - Half GV-3010-S-L Elite 8 Bio Vest - Small Left GS-3035-SH-L-R 4-Chamber Arm & Shoulder Sleeve - Large Right GBA-3045-L-2 Bio Pants - Large GXW8-3045 8-Chamber Leg Sleeve - Extra Wide GV-3010-L-L Elite 8 Bio Vest - Large Left G8-3045-L 8-Chamber Leg Sleeve - Large GV-3000 4-Chamber Vest GV-3010-M-R-BT GN-3045-L-BT GWA8-3045-S 8-Chamber Leg Sleeve - Wide Adjustable Small GWA-3045-H 4-Chamber Leg Sleeve - Wide Adjustable Half GW-3045-S-BT GWA-3045-L 4-Chamber Leg Sleeve - Wide Adjustable Large GXWA-3045 4-Chamber Leg Sleeve - Extra Wide Adjustable GBA-3045-L-R Bio Abdominal - Large Right leg GN8-3045-M 8-Chamber Leg Sleeve - Medium Narrow G8-3035-SH-M-L-BT GWA8-3045-M 8-Chamber Leg Sleeve - Wide Adjustable Medium GV-3010-L-R Elite 8 Bio Vest - Large Right GS-3035-SH-S-R 4-Chamber Arm & Shoulder Sleeve - Small Right GW8-3045-S 8-Chamber Leg Sleeve - Small Wide GS-3045-M 4-Chamber Leg Sleeve - Medium GXW-3045-BT GA-3045-L 4-Chamber Adjustable Leg Sleeve - Large GS-3035-SH-L-L 4-Chamber Arm & Shoulder Sleeve - Large Left GBA-3045-S-R Bio Abdominal - Small Right leg GXWA-3045-BT G8-3035-SH-L-L 8-Chamber Arm & Shoulder Sleeve - Large Left GN-3045-M-BT GW-3045-H 4-Chamber Leg Sleeve - Half Wide G8-3035-SH-L-R 8-Chamber Arm & Shoulder Sleeve - Large Right GA-3045-M 4-Chamber Adjustable Leg Sleeve - Medium SC-2004-DL Sequential Circulator GV-3010-S-R Elite 8 Bio Vest - Small Right GV-3010-M-L Elite 8 Bio Vest - Medium Left GA-3045-S 4-Chamber Adjustable Leg Sleeve - Small GN-3045-S-BT GS-3045-M-BT GWA-3045-S 4-Chamber Leg Sleeve - Wide Adjustable Small G8-3045-L-BT GS-3045-H 4-Chamber Leg Sleeve - Half GXW-3045 4-Chamber Leg Sleeve - Extra Wide GXWA8-3045-BT GS-3045-H-BT G8-3035-M 8-Chamber Arm Sleeve - Medium GBA-3045-L-L Bio Abdominal - Large Left leg GW-3045-S 4-Chamber Leg Sleeve - Small GS-3045-L-BT GWA8-3045-L 8-Chamber Leg Sleeve - Wide Adjustable Large GWA-3045-M 4-Chamber Leg Sleeve - Wide Adjustable Medium SC-4004-DL Sequential Circulator GBA-3045-M-L Bio Abdominal - Medium Left leg GS-3035-L 4-Chamber Arm Sleeve - Large GN-3045-L 4-Chamber Leg Sleeve - Large Narrow GBA-3045-S-2 Bio Pants - Small SC-4008-DL-BT BioTab Sequential Circulator GBA-3045-S-L Bio Abdominal - Small Left leg GW-3045-L 4-Chamber Leg Sleeve - Large GN-3045-S 4-Chamber Leg Sleeve - Small Narrow GV-3010-M-R Elite 8 Bio Vest - Medium Right GW8-3045-M-BT A8-3045-M 8-Chamber Leg Sleeve - Medium Adjustable GS-3045-S-BT GV-3010-S-2 Elite 8 Vest with Bilateral Arms - Small GN-3045-M 4-Chamber Leg Sleeve - Medium Narrow GW8-3045-S-BT GS-3035-SH-M-L-BT G8-3045-M 8-Chamber Leg Sleeve - Medium GS-3035-M-BT sequential circulator APGN-3045-FC Arterial Foot & Calf Sleeve - Narrow APG-3045-FC Arterial Foot & Calf Sleeve - Standard APGW-3045-FC Arterial Foot & Calf Sleeve - Wide APG-3035-FA Arterial Arm Sleeve IC-BAP-DX Bio Arterial Deluxe IC-BAP-DX-BT BIOARTERIAL+ Massager GWA-3045-H 4-Chamber Leg Sleeve - Wide Adjustable Half GW8-3045-S 8-Chamber Leg Sleeve - Small Wide GBA-3045-L-R Bio Abdominal - Large Right leg G8-3035-SH/L 8-Chamber Arm & Shoulder Sleeve - Large GN-3045-L 4-Chamber Leg Sleeve - Large Narrow SC-3008-DL Sequential Circulator GBA-3045-M-R Bio Abdominal - Medium Right leg SC-3008-DL-230 Sequential Circulator GV-3010-S-2 Elite 8 Vest with Bilateral Arms - Small GA-3045-H 4-Chamber Adjustable Leg Sleeve - Half GW-3045-M 4-Chamber Leg Sleeve - Medium GS-3045-M 4-Chamber Leg Sleeve - Medium GBA-3045-S-2 Bio Pants - Small GN-3045-S 4-Chamber Leg Sleeve - Small Narrow GW-3045-H 4-Chamber Leg Sleeve - Half Wide GA-3045-L 4-Chamber Adjustable Leg Sleeve - Large GWA8-3045-L 8-Chamber Leg Sleeve - Wide Adjustable Large GS-3035-SH-L-L 4-Chamber Arm & Shoulder Sleeve - Large Left G8-3035-SH-S-L 8-Chamber Arm & Shoulder Sleeve - Small Left G8-3035-SH/S 8-Chamber Arm & Shoulder Sleeve - Small G8-3035-SH-S-R 8-Chamber Arm & Shoulder Sleeve - Small Right GBA-3045-M-2 Bio Pants - Medium G8-3045-M 8-Chamber Leg Sleeve - Medium GBA-3045-L-2 Bio Pants - Large GW-3045-L 4-Chamber Leg Sleeve - Large A8-3045-S 8-Chamber Leg Sleeve - Small Adjustable GS-3045-S 4-Chamber Leg Sleeve - Small GS-3045-H 4-Chamber Leg Sleeve - Half G8-3035-SH/M 8-Chamber Arm & Shoulder Sleeve - Medium GWA-3045-M 4-Chamber Leg Sleeve - Wide Adjustable Medium GBA-3045-M-L Bio Abdominal - Medium Left leg GS-3035-SH/L 4-Chamber Arm & Shoulder Sleeve - Large GV-3010-L-2 Elite 8 Vest with Bilateral Arms - Large GWA8-3045-M 8-Chamber Leg Sleeve - Wide Adjustable Medium A8-3045-L 8-Chamber Leg Sleeve - Large Adjustable GN8-3045-L 8-Chamber Leg Sleeve - Large Narrow GV-3010-S-R Elite 8 Bio Vest - Small Right GW8-3045-M 8-Chamber Leg Sleeve - Medium Wide G8-3035-SH-M-L 8-Chamber Arm & Shoulder Sleeve - Medium Left GS-3035-M 4-Chamber Arm Sleeve - Medium GV-3010-S-L Elite 8 Bio Vest - Small Left GW8-3045-L 8-Chamber Leg Sleeve - Large Wide GW-3045-S 4-Chamber Leg Sleeve - Small GS-3035-SH-S-R 4-Chamber Arm & Shoulder Sleeve - Small Right G8-3035-SH-L-R 8-Chamber Arm & Shoulder Sleeve - Large Right GV-3010-M-R Elite 8 Bio Vest - Medium Right GN-3045-M 4-Chamber Leg Sleeve - Medium Narrow GXWA-3045 4-Chamber Leg Sleeve - Extra Wide Adjustable GS-3035-L 4-Chamber Arm Sleeve - Large GA-3045-M 4-Chamber Adjustable Leg Sleeve - Medium GBA-3045-S-L Bio Abdominal - Small Left leg GS-3035-SH-L-R 4-Chamber Arm & Shoulder Sleeve - Large Right GV-3000-8C 8-Chamber Vest SC-3004-DL Sequential Circulator G8-3045-L 8-Chamber Leg Sleeve - Large G8-3035-SH-L-L 8-Chamber Arm & Shoulder Sleeve - Large Left GXW-3045 4-Chamber Leg Sleeve - Extra Wide GBA-3045-L-L Bio Abdominal - Large Left leg GBA-3045-S-R Bio Abdominal - Small Right leg SC-3004-DL-230 Sequential Circulator GWA8-3045-S 8-Chamber Leg Sleeve - Wide Adjustable Small GXWA8-3045 8-Chamber Leg Sleeve - Extra Wide Adjustable A8-3045-M 8-Chamber Leg Sleeve - Medium Adjustable GWA-3045-S 4-Chamber Leg Sleeve - Wide Adjustable Small GA-3045-S 4-Chamber Adjustable Leg Sleeve - Small G8-3035-S 8-Chamber Arm Sleeve - Small GS-3035-SH-M-R 4-Chamber Arm & Shoulder Sleeve - Medium Right GS-3035-SH-M-L 4-Chamber Arm & Shoulder Sleeve - Medium Left GV-3010-L-L Elite 8 Bio Vest - Large Left GS-3035-SH/S 4-Chamber Arm & Shoulder Sleeve - Small GS-3035-SH-S-L 4-Chamber Arm & Shoulder Sleeve - Small Left GS-3045-L 4-Chamber Leg Sleeve - Large G8-3035-M 8-Chamber Arm Sleeve - Medium GV-3010-M-2 Elite 8 Vest with Bilateral Arms - Medium GS-3035-SH/M 4-Chamber Arm & Shoulder Sleeve - Medium GWA-3045-L 4-Chamber Leg Sleeve - Wide Adjustable Large GN8-3045-M 8-Chamber Leg Sleeve - Medium Narrow GS-3035-S 4-Chamber Arm Sleeve - Small GN8-3045-S 8-Chamber Leg Sleeve - Small Narrow GV-3000 4-Chamber Vest G8-3035-SH-M-R 8-Chamber Arm & Shoulder Sleeve - Medium Right G8-3035-L 8-Chamber Arm Sleeve - Large GV-3010-M-L Elite 8 Bio Vest - Medium Left G8-3045-S 8-Chamber Leg Sleeve - Small GXW8-3045 8-Chamber Leg Sleeve - Extra Wide GV-3010-L-R Elite 8 Bio Vest - Large Right IC-1545-DL-230 Multi-FLO DVT Combo IC-1545-DL Multi-FLO DVT Combo GC1-3045-K Cryo Knee GI-3045-F DVT Foot Sleeve (Pair) GC1-3035-SH Cryo Shoulder GID-3045-K DVT Knee High Calf Sleeve (Pair) GID-3045-T DVT Calf/Thigh Sleeve (Pair) GC1-3045-A Cryo Ankle Sequential Circulator sequential circulator GID-1000-PR VascuEase DVT Garments (Pair) IC-1200-WH VascuEase Portable DVT System 2004-OC Massage System, 2008-OC Massage System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2013-10-23
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2015-10-05
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2019-09-03
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2021-05-14
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2007-11-27
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2025-12-14
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2022-03-28
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	2013-11-11
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2013-11-11
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2015-10-05
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2013-10-23
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2007-11-27
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2007-11-27
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2018-08-15
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2013-10-23

Official Correspondent

Marc Somelofski

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Bio Compression Systems, Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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K242140	Jiale Health Technology Shenzhen Co., Ltd.	Air Compression Leg Massager (K-705)	2025-03-17

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2424387. Last updated year: 2026. Please use registration number 2424387 when referencing this establishment in official correspondence.