FDA.reportPublic FDA data

Stockinet

Primary DI
00817369020712
Brand
Stockinet
Company
NORMATEC INDUSTRIES LP
Model
"Stockinet - 8"""
Catalog number
30402
Device description
"Stockinet - 8"""
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

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
K013436000
K112890000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013436000NORMATEC PCDNormatec, Inc.2001-12-21JOW
K112890000NORMATEC MVPNormaTec Industries, LP2012-01-04IRP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817369020712PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817369020712008173690207128173690207120817369020712

GMDN Terms#

Term, Definition table
TermDefinition
Sequential venous compression systemA system used for the noninvasive treatment and prevention of venous disorders and sequelae such as oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE). It functions by applying sequential pressure to a patient's legs to promote venous blood flow. It consists of a compression pump, control/timing mechanism, tubing and has pneumatic stockings, sleeves, or a suit with several chambers that inflate and deflate sequentially in a pattern beginning at the foot or ankle and continuing to chambers around the calf and thigh. In some systems, each chamber reaches the same pressure but at different times, while others apply greater pressure distally which gradually diminishes higher up.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
111448069
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810050289252HYPERICEPRO26-SH2026-10-19
00810050289269HYPERICEPRO26-ST2026-10-19
00810050289276HYPERICEPRO26-TL2026-10-19
00810050289283HYPERICEPRO26-PH2026-10-19
00810050289290HYPERICEPRO26-PS2026-10-19
00810050289306HYPERICEPRO26-PT2026-10-19
00810050288743NormaTecNEH-252025-09-26
00810050281751NormaTecREJ62025-07-25
00810050288026Hyperice / NormaTecHX200012025-07-25
00810050288033Hyperice / NormaTecHX200022025-07-25
00810050281713NormaTecNormatec 3 Hose Attachment / REJ62024-07-26
00810050281812NormaTecNormatec 3 Right Arm Attachment/REJ62024-07-26
00810050281720NormaTecNormatec 3 Leg Attachment - Standard (Single)/REJ62023-06-16
00810050281768NormaTec Normatec 3/REJ6 Hip Attachment2023-06-16
00810050281782NormaTecNormatec 3 Arm Attachment (Pair)/REJ 62023-06-16
00810050281805NormaTecNormatec 3 Arm Attachment/REJ 62023-06-16
00810050281829NormaTecNormatec 3 Leg Attachment - Short (Single)/REJ62023-06-16
00810050281836NormaTecNormatec 3 Leg Attachment - Short (Pair)/ REJ62023-06-16
00810050281881NormaTecNormatec 3 Leg Attachment - Short Power (Single)/R2023-06-16
00810050281898NormaTecNormatec 3 Leg Attachment - Short Power (Pair)2023-06-16

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