Therabody
Sleeping Mask with vibration
437manufacturers in China registered for this device type
21catalogue 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.
| 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
| 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 | 2022-07-28 |
| Record revised | 2026-01-12 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RecoveryPulse CALF EXTRA SMALL | In distribution | |
| RecoveryPulse Arm EXTRA LARGE | In distribution | |
| RecoveryPulse CALF EXTRA LARGE | In distribution | |
| Theragun Prime 6th Gen | In distribution | |
| Theragun PRO PLUS | In distribution | |
| Theragun Prime Plus | In distribution | |
| Sleep Mask | In distribution | |
| RecoveryPulse CALF EXTRA EXTRA LARGE | In distribution | |
| RecoveryTherm Hot/Vibration Back | In distribution | |
| RecoveryPulse CALF SMALL | In distribution | |
| RecoveryPulse CALF LARGE | In distribution | |
| RecoveryPulse CALF MEDIUM | In distribution | |
| RecoveryPulse Arm MEDIUM | In distribution | |
| Theragun SENSE | In distribution | |
| RecoveryTherm Hot/Cold/Vibration Knee | In distribution | |
| RecoveryPulse Arm EXTRA SMALL | In distribution | |
| Theragun Mini Plus | In distribution | |
| RecoveryPulse Arm LARGE | In distribution | |
| Theragun Sense 2nd Gen | In distribution | |
| RecoveryPulse Arm SMALL | In distribution | |
| Theragun Relief | In distribution |
Same 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
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 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.