FDA.reportPublic FDA data

POWERPRESS UNIT

Primary DI
00860015634924
Brand
POWERPRESS UNIT
Company
NEO MEDIC
Model
P1000-TW
Catalog number
1002
Device description
Intermittent Non-Segmental Compression System Cycle Time: 60 sec, 36 sec Inflation Time / 24 sec Deflation Time Pressure Adjustable from 20 mmHg to 100 mmHg Timer: 0 - 60 Min or Continuous Mode
Published
2026-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IRPMassager, Powered Inflatable Tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRPMassager, Powered Inflatable TubePhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860015634924PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860015634924008600156349248600156349240860015634924

GMDN Terms#

Term, Definition table
TermDefinition
Pneumatic massagerAn pneumatically-powered device with a vibrating head mechanism which is typically held in the hand and drawn across the area of the body/muscles to be treated. The vibrating head or pads may be interchangeable with others of different size and shape. It can be used for respiratory and physiotherapy treatment, typically in a hospital or institution, but is also suitable for home-use.

Regulatory Flags#

DUNS number
016404090
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00086001563492POWERPRESS UNIT P1000-TW10022026-03-31
00860015634900POWERPRESS UNIT P1000-T10012026-03-31
00860015634917POWERPRESS UNIT P1000-CG10102026-03-31
00860015634931POWERPRESS UNIT P1000-TM10032026-03-31
00860015634948POWERPRESS UNIT P1000-D10072026-03-31
00860015634955POWERPRESS UNIT P1000-NAR10112026-03-31
00860015634962POWERPRESS UNIT P1000-DVT10052026-03-31
00860015634979POWERPRESS RECOVERY UNIT PR1000-T10152026-04-03

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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