What is FDA product code NGX?

A powered muscle stimulator for muscle conditioning is a device used for other than medical purposes to apply an electrical current to electrodes on a person's skin to temporarily affect the stimulated muscle's contractile properties, force output, and/or fatigue resistance. Unlike the classified Powered Muscle Stimulator devices intended for use in physical medicine and rehabilitation, this device is not intended for use in patients with medical conditions and is intended only for muscle conditioning purposes.

Physical Medicine › TherapeuticStimulator, Muscle, Powered, For Muscle Conditioning

B.Bed Evo

Name: B.Bed Evo
Brand: B.Bed Evo

The FDA filing identifies B.BED Evo as a new applicator in the BEMER Therapy System Evo submission. The B.Bed Evo is listed for local treatment on skeletal muscles of the lower extremities…

Registry build 21.09.26

The FDA filing identifies B.BED Evo as a new applicator in the BEMER Therapy System Evo submission.

The B.Bed Evo is listed for local treatment on skeletal muscles of the lower extremities and upper torso.

Applicator Characteristics

The submission describes the B.Bed Evo coil as redesigned while retaining the same power output and average flux density as the cleared B.Body Evo applicator. The system indications include temporarily increasing local blood circulation in healthy leg muscles.

66manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

1recall

Who Else Makes It

Concentrated in Guangdong (40), Beijing (10), Hebei (4). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code NGX
Manufacturer	City	Province	Registered as	Device types
Beijing Spiritlaser Science & Technology Co., Ltd.	Beijing	Beijing	Contract manufacturer	21
Shenzhen Jie Zhong Lian Technology Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	17
Dongguan Quanding Medical Supplies Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	14
Dongguan Yingfeng Metal & Plastic Products Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	14
Shenzhen Yicai Health Technology Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	10
Guangdong Ace-Tec Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	6
Shenzhen Jiantuo Electronics Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	4
Ebulent Optronics (Shenzhen) Ltd	Shenzhen	Guangdong	Contract manufacturer	4
Ansion Technology (GuangDong) Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	3
Shenzhen Life-King Technology Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	2
Beijing Choice Electronic Technololgy Co., Ltd.	Beijing	Beijing	Repacker / relabeller	30
JKH Health Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	22

Showing 12 of 66. All 66 manufacturers in China registered for Stimulator, Muscle, Powered, For Muscle Conditioning

Record

Regulatory record for B.Bed Evo
Listed by	Bemer Int. AG, LI
FDA product code	NGX
Device type	Stimulator, Muscle, Powered, For Muscle Conditioning
Device class	Class 2
Regulation	21 CFR 890.5850
Establishment	Manufacturer, Exporter
510(k)	K231368
Record published	2025-03-05

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Over the counter	Yes
Label carries	serial number

Catalogue Numbers

Catalogue numbers for B.Bed Evo
Catalogue number	Size	Status
BEMER Therapy System Evo		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
HealthmateForever	Healthmate, Inc.	74
No	Shenzhen Jian Feng Electronic Technology Co., Ltd.	39
GEM-Stim	Gemore Technology Co., Ltd.	16
HiDow	HI-DOW International Inc.	16
Auvon	Shenzhen Yuwen E-Commerce Co., Ltd.	16
Stimulator, Muscle, Powered, For Muscle Conditioning	Shenzhen Osto Medical Technology Company Limited	15
mastogo	Hong Qiangxing (Shen Zhen) Electronics Limited	15
Compex	DJO, LLC	14
Auvon	UAN Healthcare Limited	13
Belifu	Hong Qiangxing (Shen Zhen) Electronics Limited	11
Osito	Shenzhen Osto Medical Technology Company Limited	11
Domas	Hong Qiangxing (Shen Zhen) Electronics Limited	10

Showing 12 of 231. All products under Stimulator, Muscle, Powered, For Muscle Conditioning

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K231368	2023-06-09
K210174	2021-02-04
K151834	2017-02-22

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.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2021-01-13	Class II	Labeling Change Control	There potential that electromagnetic fields generated in the therapy system may cause technical defects in a patient using an insulin pumps or a malfunction of a pacemaker.	197,724 units	2023-07-12

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.