FDA.reportPublic FDA data

Pro-Daptive SensorCell Flotation Surface

Primary DI
G771PDA91003680
Brand
Pro-Daptive SensorCell Flotation Surface
Company
LEVISENSE MEDICAL, INC.
Model
PDA-9100-3680
Catalog number
MA
Device description
Pro-Daptive SensorCell Flotation Surface and Control Monitor - Size 36" x 80"
Published
2026-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FNMMattress, Air Flotation, Alternating Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNMMattress, Air Flotation, Alternating PressureGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G771PDA91003680PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Alternating-pressure bed mattress systemAn assembly of devices consisting of an alternating-pressure bed mattress (inflation-patterned air cells with or without foam component) and a dedicated electric pump, which also functions as the control unit, designed to actively alternate a bed occupant's bed-contact points, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers), patients with disabilities, or patients with low body fat.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Width0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity00

Contacts#

Phone, Email table
PhoneEmail
6178034719DaveB@levisensemedical.com

Regulatory Flags#

DUNS number
117531585
Device count
1
DM exempt
false
Premarket exempt
true
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
true
No natural rubber latex
false
Sterilization required before use
false

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00810226442023ViveVIVE HEALTH LLCFNM2026-08-19
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