Data / Medical devices / United States / Therabody, Inc.

Therabody, Inc.: FDA-registered device maker in Los Angeles, CA, United States, 8 510(k) clearances

Name: Therabody, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Therabody, Inc. is registered with the FDA (registration 3012386142) in Los Angeles, CA, United States. It lists 17 device types. The FDA files 8 510(k) clearances under its listings, the newest dated August 30, 2024. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3012386142
Address: 1640 S Sepulveda Blvd Suite 300, Los Angeles, CA, United States, 90025
Owner or operator: Therabody, Inc. (10054050)
Roles: Complaint file establishment, Specification developer
First device listed: February 6, 2017
Registered through: 2027
Brand names listed: JetBoots PRIME, JetBoots PRO Plus, MicroCurrent Gel, PowerDot 2, PowerDot PD-01M2 MuscleStimulator, RecoveryAir Half-Jacket, RecoveryAir JetBoots, RecoveryAir PRO and more

Devices it lists

Device	Product code	Class	Role	Source
Device, Pressure Applying	KNM	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Complaint file establishment	accessdata.fda.gov
Lamp, Infrared, Therapeutic Heating	ILY	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Light Based Over The Counter Wrinkle Reduction	OHS	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Massager, Powered Inflatable Tube	IRP	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Media, Electroconductive	GYB	2	Complaint file establishment	accessdata.fda.gov
Over-The-Counter Powered Light Based Laser For Acne	OLP	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Oximeter, Wellness	PGJ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Pack, Hot Or Cold, Reusable	IME	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Pad, Heating, Powered	IRT	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain Relief	GZJ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-Counter	NUH	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Stimulator, Transcutaneous Electrical, Aesthetic Purposes	NFO	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Vibrator, Therapeutic	IRO	1	Complaint file establishment, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 30, 2024	K241256	JetBoots PRO Plus	IRP	Substantially Equivalent	Therabody, Inc.	accessdata.fda.gov
June 9, 2023	K230293	TheraFace Mask	OHS	Substantially Equivalent	Therabody, Inc.	accessdata.fda.gov
December 21, 2021	K212155	TheraFace LED	OHS	Substantially Equivalent	Theragun, Inc.	accessdata.fda.gov
October 4, 2021	K211745	RecoveryAir PRO	IRP	Substantially Equivalent	Theragun, Inc.	accessdata.fda.gov
September 29, 2021	K212238	TheraFace Microcurrent	NFO	Substantially Equivalent	Theragun, Inc.	accessdata.fda.gov
July 30, 2021	K210938	PowerDot PD-01MT2 Muscle Stimulator	IPF	Substantially Equivalent	Smartmissimo Technologies Pte, Ltd.	accessdata.fda.gov
December 13, 2017	K171381	Adhesive Electrodes	GXY	Substantially Equivalent	Shenzhen Quality Medical Technology Co.,Ltd	accessdata.fda.gov
December 2, 2002	K022494	HOME CARE JELLY	GYB	Substantially Equivalent	Roc Chinese-European Industrial Research Society	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
June 23, 2026	99281	Class II	Ongoing	Charger for the Therabody Theragun, G4 PRO massage device, and products which include the 4th Generation Theragun PRO charger. G4 PRO Black US - Refurb., SKU TG02428-01 G4 PRO NA, SKU G4-PRO-PKG-NA G4-PRO-PKG-US, SKU G4	Charging cradle for the device may overheat while charging the device's removable battery pack, presenting risk of thermal event (fire). Firm has received reports alleging the product caught fire and other reports regarding visible smoke, melting, charger burn, burning odor, and overheating.	accessdata.fda.gov

Compare with other makers

Updated July 31, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.