Therabody - Theragun, Inc

Duns Number:080550811

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More Product Details

Catalog Number

-

Brand Name

Therabody

Version/Model Number

RecoveryPulse Arm MEDIUM

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

ISA

Product Code Name

Massager, Therapeutic, Electric

Device Record Status

Public Device Record Key

b2e5fcdf-de3e-4652-a9a4-473860023473

Public Version Date

August 05, 2022

Public Version Number

1

DI Record Publish Date

July 28, 2022

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