Air Relax Plus Model AR-3.0 Leg Recovery System - Size 4

GUDID 08809040526400

Air Relax Plus Model AR-3.0 Leg Recovery System - Size 4

Maxstar Industrial Co.,Ltd.

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Primary Device ID08809040526400
NIH Device Record Key88bb0e1f-b28f-4698-9418-41d00d8f36c0
Commercial Distribution StatusIn Commercial Distribution
Brand NameAir Relax Plus Model AR-3.0 Leg Recovery System - Size 4
Version Model NumberAR3-S4
Company DUNS687844027
Company NameMaxstar Industrial Co.,Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS108809040526400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IRPMassager, Powered Inflatable Tube

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-21
Device Publish Date2021-07-13

Devices Manufactured by Maxstar Industrial Co.,Ltd.

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08809040526820 - Air Relax Classic Model AR-2.0 Leg Recovery System - Size 22021-07-28 Air Relax Classic Model AR-2.0 Leg Recovery System - Size 2 (110V US PLUG - TYPE A)
08809040526837 - Air Relax Classic Model AR-2.0 Leg Recovery System - Size 32021-07-28 Air Relax Classic Model AR-2.0 Leg Recovery System - Size 3 (110V US PLUG - TYPE A)
08809040526844 - Air Relax Classic Model AR-2.0 Leg Recovery System - Size 42021-07-28 Air Relax Classic Model AR-2.0 Leg Recovery System - Size 4 (110V US PLUG - TYPE A)
08809040526271 - Air Relax Plus Model AR-3.0 Control Unit Only2021-07-23 Air Relax Plus Model AR-3.0 Control Unit Only
08809040526288 - Air Relax Plus Model AR-3.0 & AR-2.0 Leg Sleeves - Size 22021-07-23 Air Relax Plus Model AR-3.0 & AR-2.0 Leg Sleeves - Size 2
08809040526295 - Air Relax Plus Model AR-3.0 & AR-2.0 Leg Sleeves - Size 32021-07-23 Air Relax Plus Model AR-3.0 & AR-2.0 Leg Sleeves - Size 3
08809040526301 - Air Relax Plus Model AR-3.0 & AR-2.0 Leg Sleeves - Size 42021-07-23 Air Relax Plus Model AR-3.0 & AR-2.0 Leg Sleeves - Size 4

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