Facility

Therabody Australia Pty. Ltd.

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3023613474
Establishment type	Export Device to the United States But Perform No Other Operation on Device
Location	Waterman Business Centre Ringwood Victoria, AU 3134
Registration status	Active · expires 2026
Parent company	Therabody, Inc. (owner-operator 10054050)
Brand names	PowerDot PD-01M2 MuscleStimulator; PowerDot 2

Activity by year

Recalls (1)

Devices registered here (4)

Stimulator, Nerve, Transcutaneous, For Pain Relief
Product code GZJ (opens in a new tab) · Class II · Neurology · 21 CFR 882.5890
Stimulator, Muscle, Powered, For Muscle Conditioning
Product code NGX (opens in a new tab) · Class II · Physical Medicine · 21 CFR 890.5850
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Product code NUH (opens in a new tab) · Class II · Neurology · 21 CFR 882.5890
Stimulator, Muscle, Powered
Product code IPF (opens in a new tab) · Class II · Physical Medicine · 21 CFR 890.5850

Recalls & enforcement

Class IIOngoing2026-06-23
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 …

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Therabody Australia Pty. Ltd. (FEI 3023613474) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3023613474-therabody-australia-pty-ltd/

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