FDA.reportPublic FDA data

NormaTec

Primary DI
00810050281805
Brand
NormaTec
Company
NORMATEC INDUSTRIES LP
Model
Normatec 3 Arm Attachment/REJ 6
Device description
Normatec 3 Left Arm Attachment
Published
2023-06-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K183328000
K220217000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183328000Pulse Rx 2.0, Pulse Pro Rx 2.0NormaTec Industries, LP2018-12-21JOW
K220217000Normatec 3NormaTec Industries, LP2022-02-25IRP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810050281805PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810050281805008100502818058100502818050810050281805

GMDN Terms#

Term, Definition table
TermDefinition
Multi-chamber venous compression system garment, reusableAn inflatable device in the form of a stocking, sleeve, or suit that is applied to the limbs externally to promote venous blood flow. As part of a compression system, the device applies pressure to the extremities through the sequential inflation of several chambers. The resulting increased venous blood flow may help to treat/prevent oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE) in non-ambulatory patients or patients at risk. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
111448069
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
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
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
00810050281911NormaTecNormatec 3 Leg Attachment - Standard Power (Single2023-06-16

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