FDA.report

Protekt Seat Relief

Primary DI
05060488570223
Brand
Protekt Seat Relief
Company
PROACTIVE MEDICAL PRODUCTS, LLC
Model
80121
Catalog number
80121
Device description
PROTEKT SEAT RELIEF ALTERNATING PRESSURE SEAT CUSHION SYSTEM 18"
Published
2016-08-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FNMMattress, Air Flotation, Alternating Pressure

Product Code Classifications

CodeDeviceSpecialtyClass
FNMMattress, Air Flotation, Alternating PressureGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05060488570223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05060488570223050604885702235060488570223

GMDN Terms

TermDefinition
Alternating-pressure chair cushion, reusableA pad intended to be placed on the seat of a chair and designed with parallel chambers that are alternately filled with forced-air to actively change an occupant's buttocks-chair contact points, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized patients especially in cases of decubitus ulcers, patients with disabilities, or patients with low body fat. This is a reusable device.

Device Sizes

TypeValueUnit
Height3Inch
Length16Inch
Width18Inch

Sterilization Methods

Method

Contacts

PhoneEmail
+1 855 237 7622sales@proactivemedical.com

Regulatory Flags

DUNS number
078582655
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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