FDA.reportPublic FDA data

NormaTec

Primary DI
00810050282123
Brand
NormaTec
Company
NORMATEC INDUSTRIES LP
Model
Normatec 3 Leg Attachment - Tall (Pair)/ REJ6
Device description
Normatec 3 Tall Pair Leg 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
00810050282123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810050282123008100502821238100502821230810050282123

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
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
00810050281911NormaTecNormatec 3 Leg Attachment - Standard Power (Single2023-06-16
00810050281928NormaTecNormatec 3 Leg Attachment - Standard Power (Pair)/2023-06-16
00810050281942NormaTecNormatec 3 Leg Attachment - Tall Power (Single)/ R2023-06-16
00810050281959NormaTecNormatec 3 Leg Attachment - Tall Power (Pair)/REJ62023-06-16
00810050282093NormaTec Normatec 3 Leg Attachment - Standard (Pair)/ REJ62023-06-16
00810050282116NormaTecNormatec 3 Leg Attachment - Tall (Single)/REJ62023-06-16

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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