Recently, the State Food and Drug Administration announced the 17th National Medical Device Quality Announcement in 2017, for the medical oxygen concentrator (medical oxygen generator), disposable sterile syringe (with needle) and other three varieties of 202 batches The quality supervision and sampling inspection of the products was announced. Among them, the medical equipment products that are not in compliance with the standards are 13 batches (sets) of 13 varieties of 13 medical device manufacturers; the items to be inspected are medical device products that do not meet the standard requirements, such as labeling labels and instructions. There are 4 varieties of 2 medical device manufacturers; the sampling equipments all meet the standard requirements, and the medical device products involve 184 batches (sets) of 3 varieties of 128 medical device manufacturers.

At present, the State Food and Drug Administration has requested that the food and drug supervision and administration departments of product companies and agents where they do not meet the standards should investigate and deal with relevant enterprises. And the relevant provincial food and drug supervision and administration departments are required to promptly disclose the disposal situation to the public.

In order to strengthen the quality supervision and management of medical devices and ensure the safe and effective use of medical device products, the State Food and Drug Administration has organized three varieties of medical oxygen concentrators (medical oxygen generators) and disposable sterile syringes (with needles). The batch (Taiwan) products were subjected to quality supervision and sampling. The results of the random inspection are now announced as follows:

1. The medical device products that are not in compliance with the standard are required to be sampled, involving 13 varieties (sets) of 3 varieties of 13 medical device manufacturers. Specifically:

(1) Medical oxygen concentrators (medical oxygen generators) 5 products from 4 companies. A small medical molecular sieve oxygen generator produced by Hangzhou Chuangwei Air Separation Technology Co., Ltd. does not meet the standard input power; two KH medical oxygen generators produced by Shandong Kehua Health Technology Co., Ltd., Chatter Biomedical (Chengdu) ) A portable oxygen concentrator produced by the company, the outlet pressure does not meet the standard; a Jijia medical oxygen generator produced by Jilin Aierkang Medical Instrument Co., Ltd., oxygen concentration status indicator, lost grid voltage indication The device does not meet the standards.

(2) Disposable sterile syringes (with needles) 1 batch of products from 1 company. One batch of single-use sterile syringes (with needles) produced by Henan Yu'an Medical Devices Co., Ltd., the needle pin connection firmness does not meet the standard.

(3) 9 batches of products from 8 enterprises of sterile vaginal dilators. Guangdong Integrity Medical Devices Co., Ltd., Shenzhen Security Medical Products Co., Ltd., Henan Yadu Industrial Co., Ltd., Shantou Huaeryi Medical Devices Co., Ltd., Guangzhou Huashan Medical Plastics Factory, Jiangxi Hongda Medical Devices Group Co., Ltd., Hunan Ping An Two batches of one-time use sterile vaginal dilator produced by Changzhou Huankang Medical Devices Co., Ltd., each batch produced by Machinery Technology Co., Ltd., the ethylene oxide residue does not meet the standard.

The above sampling does not meet the specific conditions of the product specified in the standard, see Annex 1.

2. The sample items to be inspected are medical device products that do not meet the standards as specified in the label, instruction manual, etc., involving 4 types of 2 medical device manufacturers, specifically:

Medical oxygen concentrator (medical oxygen generator) 4 products in 2 companies. The three medical oxygen generators produced by Foshan Shunde Key Electronics Co., Ltd. and one small medical molecular sieve oxygen generator produced by Hangzhou Chuangwei Air Separation Technology Co., Ltd. do not comply with the standard.

The above sampling does not meet the specific conditions of the product specified in the standard, see Annex 2.

3. All the sampling equipments that meet the standard requirements include 184 batches (sets) of 3 varieties of 128 medical device manufacturers, see Annex 3.

4. The State Food and Drug Administration has requested the food and drug supervision and administration department of the locality to comply with the Regulations on the Supervision and Administration of Medical Devices and the General Office of the Food and Drug Administration to further strengthen medical devices. Notice of Sampling Work (Food and Drug Supervision Office Supervision [2016] No. 9), investigate and deal with relevant enterprises.

Relevant medical device manufacturers shall conduct risk assessments for products that do not meet the standards and products that do not meet the standards, determine the recall level according to the severity of the medical device defects, and actively recall and publicly recall the information. The food and drug supervision and administration department of the enterprise shall supervise the recall of the enterprise, and shall not recall the recall of the organization; if it is found that the medical device product does not meet the standards and cause harm to the human body or there is evidence that it may endanger human health, it may suspend production. Emergency control measures for operation and use. Relevant provincial food and drug supervision and administration departments should urge enterprises to ascertain the reasons as soon as possible, formulate corrective measures and rectify them in time, and the relevant disposals will be announced to the public before August 31, 2017.

Special announcement.

Attachment: 1. National medical device sampling inspection does not meet the standard list of products

2. National medical device sampling (labels and labels, etc.) does not meet the standard list of products

3. National medical device sampling inspection meets the standard list of products

Food and Drug Administration

August 4, 2017

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