Bite Away

The bite away® is a handheld device that allows the user to apply a therapeutic dose of heat directly to an insect sting or bite and is clinically proven to provide temporary relief of the…

Registry build 21.09.26

The bite away® is a handheld device that allows the user to apply a therapeutic dose of heat directly to an insect sting or bite and is clinically proven to provide temporary relief of the resulting itching, pain and swelling. If the device is applied immediately after the sting or bite, the symptoms can usually be prevented completely. Even if the device is used slightly later, the symptoms can still subside sooner. bite away® works solely by concentrated heat and is thus completely free from chemicals (also suitable for pregnant women, allergy sufferers and children).

144manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (69), Zhejiang (25), Jiangsu (11). 16 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code IRT
Manufacturer City Province Registered as Device types
Hengshui Gangsheng Medical Instruments Co., Ltd. Hengshui Hebei Contract manufacturer 36
Shanghai Care Us Medical Product Co., Ltd. Shanghai Shanghai Contract manufacturer 30
Dongguan BAO Kang Dian ZI KE JI Limited Dongguan Guangdong Contract manufacturer 24
Dongguan Yingfeng Metal & Plastic Products Co., Ltd. Dongguan Guangdong Contract manufacturer 14
Aopu Lighting (Jinyun) Co., Ltd. Lishui Zhejiang Contract manufacturer 9
Shenzhen Xiangzhida Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 7
Jiangsu Alphay Medical Device Co., Ltd. Nantong Jiangsu Contract manufacturer 6
Shanghai GK Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 5
Zhongshan GL Electronics Co., Ltd. Zhongshan Guangdong Contract manufacturer 5
Xiamen Ubest Electronic Technology Co., Ltd. Xiameng Fujian Contract manufacturer 3
Eagle Electric(Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 2
Ezra Innovation (Dong guan) Limited Dongguan Guangdong Contract manufacturer 2

Showing 12 of 144. All 144 manufacturers in China registered for Pad, Heating, Powered

Record

Regulatory record for bite away
Listed by Mibetec Gmbh, Germany
FDA product code IRT
Device type Pad, Heating, Powered
Device class Class 2
Regulation 21 CFR 890.5740
Establishment Manufacturer
510(k) K160943
Record published 2020-02-06
Record revised 2021-08-09 (version 4)

Specifications

Specifications
MRI safety MR Unsafe
Over the counter Yes
Label carries lot or batch number, manufacturing date
Packaging 2-pack(bundl) of 2, 3-pack(bundl) of 3, 5-pack(bundl) of 5

Catalogue Numbers

Catalogue numbers for bite away
Catalogue number Size Status
VI00545 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Sunbeam Jarden Consumer Solutions 182
UTK UTK Technology(Shenzhen)Limited 66
Pure Enrichment Bear Down Consulting 62
HealthyLine Imedia NY Inc 55
Homedics FKA Distributing Co., LLC 34
CVS Health Woonsocket Prescription Center, Incorporated 28
Thermophore Battle Creek Equipment 23
Renpho Heating Pad Joicom Corporation 22
Walgreens Walgreen Co. 21
Sharper Image Zhejiang Lumeng Health & Technology Co., Ltd. 20
SpeedHeat Inspiration Medical Technology, Inc. 19
Venture Heat Matsum Inc 18

Showing 12 of 165. All products under Pad, Heating, Powered

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K250047 2025-09-12
K220514 2022-06-23

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