FDA.reportPublic FDA data

Bio Compression Systems Cryo Insert Back - Black

Primary DI
00812311021663
Brand
Bio Compression Systems Cryo Insert Back - Black
Company
Bio Compression Systems, Inc
Model
CI-3035-B/B
Published
2017-11-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IRPMassager, Powered Inflatable Tube
JOWSLEEVE, LIMB, COMPRESSIBLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRPMassager, Powered Inflatable TubePhysical Medicine2
JOWSleeve, Limb, CompressibleCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961425000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961425000BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER SEQUENTIAL MODELSBio Compression Systems, Inc.1996-10-28ILO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812311021663PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812311021663008123110216638123110216630812311021663

GMDN Terms#

Term, Definition table
TermDefinition
Inflatable hot/cold therapy pack/electric pumpA non-sterile assembly of devices intended for localized thermal and compression therapy to facilitate the treatment of a variety of adverse conditions resulting from musculoskeletal injury (e.g., pain, swelling, inflammation). It includes one or more hot and/or cold therapy packs with an air inflation sleeve, a mains electricity (AC-powered) air pump with controls, and air-conduction tubing; the pack(s) is heated/cooled independently of the system (e.g., cooled using chilling unit) and may be anatomically specific. The unit may be programmed for selected treatment plans. It is intended for use in both professional and home settings.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(201)340-6422barbaraw@biocompression.com

Regulatory Flags#

DUNS number
101393924
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812311022448Sequential CirculatorSC-4104-DL2026-09-29
00812311022486Sequential CirculatorSC-4108-DL2026-09-29
00812311022363BIOARTERIAL+IC-BAP-DX-BT2026-03-09
00812311022479Bio Arterial DeluxeIC-BAP-DX2026-02-13
00812311020512Multi-FLO DVT Combo Cyro Shoulder SleeveGC1-3035-SH2019-04-09
00812311020543Multi-FLO DVT Combo Cyro Ankle SleeveGC1-3045-A2019-04-09
00812311020567Multi-FLO DVT Combo Cyro Knee SleeveGC1-3045-K2019-04-09
00812311024244BioTab Sequential CirculatorSC-2004-DL-BT2021-08-31
00812311024480BioTab Sequential CirculatorSC-4008-DL-BT2021-08-31
00812311026149Sequential CirculatorSC-1004-DL2021-08-31
00812311026187Sequential CirculatorSC-1008-DL2021-08-31
00812311026248Sequential CirculatorSC-2004-DL2021-08-31
00812311026286Sequential CirculatorSC-2008-DL2021-08-31
00812311026446Sequential CirculatorSC-4004-DL2021-08-31
00812311026484Sequential CirculatorSC-4008-DL2021-08-31
00812311026255BioCryo Sequential CirculatorSC-2004-DL-OTC2022-04-13
00812311020086Bio Compression Systems Carrying Case BlueBCC-1002017-11-21
00812311020871Bio Compression Systems Sequential Circulator Model SC-2004SC-20042017-11-21
00812311021199Bio Compression Systems Bio Arterial Plus Model IC-BAPIC-BAP2017-11-21
00812311021205Bio Compression Systems Bio Arterial Plus Model IC-BAP-230IC-BAP-2302017-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810050289252HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
00810050289269HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
00810050289276HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
00810050289283HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
00810050289290HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
00810050289306HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
06959557201382Air Compression Therapy DeviceSHENZHEN FUTURE ELECTRONIC CO.,LTDIRP2026-10-15
03858894530502ZT Cube - ZC3ZAMAR MEDICAL d.o.o.IRP2026-10-12
03858894530618ZT CLINICZAMAR MEDICAL d.o.o.IRP2026-10-12
06976331781397AnacondafightwearHuizhou XINYI Technology Co., LTDIRP2026-10-12
06959557201375Air Compression Therapy DeviceSHENZHEN FUTURE ELECTRONIC CO.,LTDIRP2026-10-10
00850031012769AIROSAIROS MEDICAL INCJOW2026-10-09
06959557200286Powered Inflatable Tube MassagerSHENZHEN FUTURE ELECTRONIC CO.,LTDIRP2026-09-30
00812311022448Sequential CirculatorBio Compression Systems, IncJOW2026-09-29
00812311022486Sequential CirculatorBio Compression Systems, IncJOW2026-09-29
06974000130033HealthpalXiamen Healthpal Electronic Co., Ltd.IRP2026-08-26
00190446979128AIRCASTDJO, LLCJOW2026-08-03
00812120004895Game Ready* SystemAvanos Medical, Inc.IRP2026-07-31
00812120005076Game Ready* Full Leg Boot Wrap, MediumAvanos Medical, Inc.IRP2026-07-31
00812120005113Game Ready* Ankle Wrap, LargeAvanos Medical, Inc.IRP2026-07-31
00812120005120Game Ready* Ankle Wrap, Extra LargeAvanos Medical, Inc.IRP2026-07-31
00812120005137Game Ready* Shoulder Wrap, Medium, RightAvanos Medical, Inc.IRP2026-07-31
00812120005144Game Ready* Shoulder Wrap, Medium, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005151Game Ready* Shoulder Wrap, Large, RightAvanos Medical, Inc.IRP2026-07-31
00812120005168Game Ready* Shoulder Wrap, Large, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005175Game Ready* Back WrapAvanos Medical, Inc.IRP2026-07-31
00812120005182Game Ready* C-T Spine Wrap, LargeAvanos Medical, Inc.IRP2026-07-31
00812120005199Game Ready* Hip/Groin Wrap, RightAvanos Medical, Inc.IRP2026-07-31
00812120005205Game Ready* Hip/Groin Wrap, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005212Game Ready* Hand/Wrist WrapAvanos Medical, Inc.IRP2026-07-31