FDA.reportPublic FDA data

Bio Compression Systems Cryo Insert Knee - Black

Primary DI
00812311020192
Brand
Bio Compression Systems Cryo Insert Knee - Black
Company
Bio Compression Systems, Inc
Model
CI-3045-K/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
00812311020192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812311020192008123110201928123110201920812311020192

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
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
00812311021212Bio Compression Systems Bio Arterial Plus Model IC-BAP-DLIC-BAP-DL2017-11-21
00812311021229Bio Compression Systems Sequential Circulator Model SC-2004-230SC-2004-2302017-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00812120005229Game Ready* Flexed Elbow WrapAvanos Medical, Inc.IRP2026-07-31
00812120005236Game Ready* Half Leg Boot WrapAvanos Medical, Inc.IRP2026-07-31
00812120005243Game Ready* Full Leg Boot Wrap, LargeAvanos Medical, Inc.IRP2026-07-31
00812120005250Game Ready* Straight Knee SleeveAvanos Medical, Inc.IRP2026-07-31
00812120005267Game Ready* Articulated Knee SleeveAvanos Medical, Inc.IRP2026-07-31
00812120005274Game Ready* Straight Elbow SleeveAvanos Medical, Inc.IRP2026-07-31
00812120005281Game Ready* Ankle Sleeve, LargeAvanos Medical, Inc.IRP2026-07-31
00812120005298Game Ready* Ankle Sleeve, Extra LargeAvanos Medical, Inc.IRP2026-07-31
00812120005304Game Ready* Shoulder Sleeve, Medium, RightAvanos Medical, Inc.IRP2026-07-31
00812120005311Game Ready* Shoulder Sleeve, Medium, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005328Game Ready* Shoulder Sleeve, Large, RightAvanos Medical, Inc.IRP2026-07-31
00812120005335Game Ready* Shoulder Sleeve, Large, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005342Game Ready* Back SleeveAvanos Medical, Inc.IRP2026-07-31
00812120005359Game Ready* C-T Spine Sleeve, LargeAvanos Medical, Inc.IRP2026-07-31
00812120005366Game Ready* Hip/Groin Sleeve, RightAvanos Medical, Inc.IRP2026-07-31
00812120005373Game Ready* Hip/Groin Sleeve, LeftAvanos Medical, Inc.IRP2026-07-31