Who else makes this device?

Name: RehaStim2
Brand: RehaStim2

Neurology › TherapeuticStimulator, Neuromuscular, External Functional

RehaStim2

External Functional Neuromuscular Stimulator (8 channels), designed for use as stand-alone device as well as in combination with exercise equipment for walking and cycling applications,…

Registry build 21.09.26

External Functional Neuromuscular Stimulator (8 channels), designed for use as stand-alone device as well as in combination with exercise equipment for walking and cycling applications, that has been validated for compatibility by HASOMED GmbH and should be used under the supervision of a clinician. – manufactured for use in system

8manufacturers in China registered for this device type

1catalogue number

4510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (6), Jiangsu (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GZI
Manufacturer	City	Province	Registered as	Device types
JKH Health Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	22
Suzhou Fast ATM Electric Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	2
Shenzhen Dongdixin Technology Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	18
Netop Industrial Company Limited	Dongguan	Guangdong	Manufacturer	14
Devon Medical Products (Jiangsu) Ltd	Nantong	Jiangsu	Repacker / relabeller	12
Guangzhou Longest Medical Technology Co., Ltd.	Guangzhou	Guangdong	Manufacturer	9
Shenzhen XFT Medical Limited	Shenzhen	Guangdong	Manufacturer	8
Xemis Medical Technology (Shenzhen) Co., Ltd.	Shenzhen	Guangdong	Manufacturer	6

Record

Regulatory record for RehaStim2
Listed by	Hasomed Gmbh, Germany
FDA product code	GZI
Device type	Stimulator, Neuromuscular, External Functional
Device class	Class 2
Regulation	21 CFR 882.5810
Establishment	Manufacturer
510(k)	K162683
Record published	2020-11-22

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	serial number

Catalogue Numbers

Catalogue numbers for RehaStim2
Catalogue number	Size	Status
FES01092		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
L300 Go System	Bioness Medical, Inc.	22
RT300	Restorative Therapies Inc.	20
H200 Wireless System	Bioness Medical, Inc.	20
Chattanooga	DJO, LLC	17
Cionic	Cionic	6
L100 Go System	Bioness Medical, Inc.	4
MyndStep	Myndtec Inc	4
ReGrasp	Rehabtronics, Inc.	4
XFT	Shenzhen XFT Medical Limited	3
RT200	Restorative Therapies Inc.	2
RehaStim 2	Hasomed Gmbh	2
H200 Wireless	Bioness Medical, Inc.	2

Showing 12 of 53. All products under Stimulator, Neuromuscular, External Functional

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K162683	2017-02-03
K132416	2014-05-28
K112844	2011-10-27
K073237	2007-12-27

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.