RecoveryAir - Powered inflatable tube massager - Theragun, Inc

Duns Number:080550811

Device Description: Powered inflatable tube massager

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More Product Details

Catalog Number

-

Brand Name

RecoveryAir

Version/Model Number

Compression Pants

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 22, 2021

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

IRP

Product Code Name

Massager, Powered Inflatable Tube

Device Record Status

Public Device Record Key

78453004-5f11-47d8-a9bd-f2ed7364ebc8

Public Version Date

December 30, 2021

Public Version Number

1

DI Record Publish Date

December 22, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"THERAGUN, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 26
2 A medical device with a moderate to high risk that requires special controls. 23