BioTab

BT Lymphedema Pump (PCB) 8 Chamber Replacement Sleeves (Medium Wide)

Registry build 21.09.26
37manufacturers in China registered for this device type
23catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (17), Fujian (10), Zhejiang (4). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code IRP
Manufacturer City Province Registered as Device types
Dongguan BAO Kang Dian ZI KE JI Limited Dongguan Guangdong Contract manufacturer 24
Ningbo Albert Novosino Co., Ltd. Yuyao Zhejiang Contract manufacturer 17
Alleva Medical (D.G.) Ltd Dongguan Guangdong Contract manufacturer 13
Shenzhen Yicai Health Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 10
Zhangzhou Easepal Innovation Co., Ltd. Zhangzhou Fujian Contract manufacturer 7
Grandway Technology (Shenzhen) Limited Shenzhen Guangdong Contract manufacturer 6
Shanghai Youwen Medical Technology Co., Ltd. Shanghai Shanghai Contract manufacturer 2
Ryder Electronics (Xinfeng) Ltd. Ganzhou Jiangxi Contract manufacturer 1
Foshan Hongfeng Co., Ltd. Foshan Guangdong Contract manufacturer 24
JKH Health Co., Ltd. Dongguan Guangdong Contract manufacturer 22
Fofo Medical Co., Ltd. Xiamen Fujian Exporter 18
Shenzhen Ruiyi Business Technology Co., Ltd. Shenzhen Guangdong Specification developer 13

Showing 12 of 37. All 37 manufacturers in China registered for Massager, Powered Inflatable Tube

Record

Regulatory record for BioTab
Listed by Vive Health LLC, United States
FDA product code IRP
Device type Massager, Powered Inflatable Tube
Device class Class 2
Regulation 21 CFR 890.5650
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k) K201982
Record published 2025-02-04
Record revised 2025-08-15 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Over the counter Yes
Packaging Case of 8, case of 2, case
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for BioTab
Catalogue number Size Status
RHB3044BLKSW In distribution
RHB3044MW2PAK In distribution
RHB3044L2PAK In distribution
RHB3023BLKS In distribution
RHB3023BLKL In distribution
RHB3044BLKMW In distribution
RHB3044XW2PAK In distribution
RHB3023SLEMW In distribution
RHB3023BLKEW In distribution
RHB3045RM In distribution
RHB3023BLKM In distribution
RHB3023SLES In distribution
RHB3023BLKSW In distribution
RHB3023SLEM In distribution
RHB3044BLKS In distribution
RHB3044ESW2PAK In distribution
RHB3044BLKXW In distribution
RHB3045LM In distribution
RHB3044BLKM In distribution
RHB3044S2PAK In distribution
RHB3044M2PAK In distribution
RHB3023BLKMW In distribution
RHB3044BLKL In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
LF900 Daesung Maref Co., Ltd. 69
LX9max Daesung Maref Co., Ltd. 47
Game Ready Avanos Medical, Inc. 34
Compressible Limb Therapy System(LX7(V7)) Daesung Maref Co., Ltd. 30
VU Xiamen Weiyou Intelligent Technology Co., Ltd. 28
NormaTec Normatec Industries, LP 27
SP-2000 Daesung Maref Co., Ltd. 23
Rapid Reboot Rapid Reboot Recovery Products 22
4 chamber sleeve Daesung Maref Co., Ltd. 21
SP-1000 Daesung Maref Co., Ltd. 19
Homedics FKA Distributing Co., LLC 18
CoreTech Vive Health LLC 17

Showing 12 of 230. All products under Massager, Powered Inflatable Tube

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