Aura Wellness

The Nova HD Pulsed Electronic Therapy device from Aura Wellness has been designed specifically for the Human Healthcare Market. Using state of the art design concepts and Human Factor…

Registry build 21.09.26

The Nova HD Pulsed Electronic Therapy device from Aura Wellness has been designed specifically for the Human Healthcare Market. Using state of the art design concepts and Human Factor Principles, The Aura is easy to operate and incorporates many features to promote human health and well-being. The Nova HD is ideal for all strenuous sports and physical labor recovery as well as for any nuisance aches and pains which may be affecting the users total health and wellness. The Nova HD is a total body wellness device. We also provide many coil attachments designed for use with the Nova HD on various parts of the body. The Nova HD is intended to be operated and used by the same person. The Nova HD produces non ionizing pulsed electromagnetic field at the applicator.

437manufacturers in China registered for this device type
10catalogue numbers in this listing

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 Aura Wellness
Listed by Aura Wellness, LLC, United States
FDA product code ISA
Device type Massager, Therapeutic, Electric
Device class Class 1
Regulation 21 CFR 890.5660
Establishment Manufacturer
Premarket notification Exempt
Record published 2023-09-06
Record revised 2025-12-09 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Supplied as a kit Yes
Label carries lot or batch number, manufacturing date, serial number
Storage Storage environment temperature -25 to 70 °C; Storage environment atmospheric pressure 525 to 795 Millimeter of Mercury; Storage environment humidity 15 to 90 % RH
Distribution end date 2025-12-08

Catalogue Numbers

Catalogue numbers for Aura Wellness
Catalogue number Size Status
Half Body Mat In distribution
Large Loop In distribution
Butterfly Loop In distribution
Wings In distribution
Aura Wave Starter Kit Withdrawn
Aura Wave Withdrawn
Nova HD Withdrawn
Aura Pulse Starter Kit Withdrawn
Nova HD Starter Kit Withdrawn
Aura Pulse Withdrawn

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

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