Therabody, Inc.
Los Angeles, CA, US
Therabody, Inc. appears in FDA device records in Los Angeles, CA. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 2 510(k) clearances for Therabody, Inc. between 2023 and 2024. The busiest year on record is 2023, with 1. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2023 | 1 |
| 2024 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3012386142 | 3012386142 | Therabody, Inc. | 1640 S Sepulveda Blvd, Los Angeles, CA 90025 US | 2026 | and 7 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KNMDevice, Pressure Applying
- GXYElectrode, Cutaneous
- ILYLamp, Infrared, Therapeutic Heating
- OHSLight Based Over The Counter Wrinkle Reduction
- IRPMassager, Powered Inflatable Tube
- ISAMassager, Therapeutic, Electric
- GYBMedia, Electroconductive
- OLPOver-The-Counter Powered Light Based Laser For Acne
- PGJOximeter, Wellness
- IMEPack, Hot Or Cold, Reusable
- IRTPad, Heating, Powered
- IPFStimulator, Muscle, Powered
- NGXStimulator, Muscle, Powered, For Muscle Conditioning
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief
- NUHStimulator, Nerve, Transcutaneous, Over-The-Counter
- NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes
- IROVibrator, Therapeutic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2835-2026 | 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 PRO US G4 PRO Black US - Refurb V, SKU TG0002428-1V10 Pro Charger Single Unit, SKU PRO-CHARGER-SINGLE | 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. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain
