Theragun

Hand held massager

Registry build 21.09.26
437manufacturers in China registered for this device type
8catalogue numbers in this listing
1recall

Who Else Makes It

Concentrated in Guangdong (213), Zhejiang (102), Fujian (43). 45 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code ISA
Manufacturer City Province Registered as Device types
Hospital & Homecare IMP. & EXP. Co., Ltd. Nanjing Jiangsu Contract manufacturer 179
Ningbo Castle Medical Import & Export Co., Ltd. Ningbo Zhejiang Contract manufacturer 67
Foshan Hongfeng Co., Ltd. Foshan Guangdong Contract manufacturer 24
Dongguan BAO Kang Dian ZI KE JI Limited Dongguan Guangdong Contract manufacturer 24
Guangzhou Xinbo Electronic Co., Ltd. Guangzhou Guangdong Contract manufacturer 18
Ningbo Albert Novosino Co., Ltd. Yuyao Zhejiang Contract manufacturer 17
Beilun Plastech Inc Ningbo Zhejiang Contract manufacturer 13
Shenzhen Roundwhale Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 8
Zhangzhou Easepal Innovation Co., Ltd. Zhangzhou Fujian Contract manufacturer 7
Shenzhen Xiangzhida Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 7
Jiangsu Alphay Medical Device Co., Ltd. Nantong Jiangsu Contract manufacturer 6
Taizhou Rapson Glasses Co., Ltd. Linhai Zhejiang Contract manufacturer 6

Showing 12 of 437. All 437 manufacturers in China registered for Massager, Therapeutic, Electric

Record

Regulatory record for Theragun
Listed by Therabody, Inc., United States
FDA product code ISA
Device type Massager, Therapeutic, Electric
Device class Class 1
Regulation 21 CFR 890.5660
Establishment Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2021-09-29
Record revised 2024-09-18 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Latex Labelled latex-free
Label carries lot or batch number, serial number

Catalogue Numbers

Catalogue numbers for Theragun
Catalogue number Size Status
Theragun PRO In distribution
Wave Roller In distribution
Theragun Elite In distribution
Theragun Mini In distribution
Theragun Prime In distribution
Theragun Elite In distribution
Wave Duo In distribution
Wave Solo In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Human Touch Human Touch, LLC. 190
Homedics Health Care Massage Branch of Zhangzhou Easepal Industrial Corporation 102
Conair Conair LLC. 87
Sharper Image Merchsource LLC 62
Renpho Joicom Corporation 59
3H 3H Co., Ltd. 48
silverfox Silverfox Corporation Limited 35
Thermage Solta Medical, Inc. 35
Renpho Eye Massager Joicom Corporation 32
Homedics Smart Home Branch of Zhangzhou Easepal Industrial Corporation 28
G5® General Physiotherapy, Inc. 26
Homedics Zhangzhou Easepal Innovation Co., Ltd. 23

Showing 12 of 249. All products under Massager, Therapeutic, Electric

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Theragun
Recalled by Identified by Initiated FDA class Root cause Reason Quantity
Therabody, Inc. UDI-DI 2026-06-23 Class II Under Investigation by firm 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, m 584224

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer