Mychway Co. Ltd.

⚠️ Moderate Risk

FEI: 3009052317 • Shenzhen • CHINA

FEI

FEI Number

3009052317

📍

Location

Shenzhen

🇨🇳

Country

CHINA

🏢

Address

Pengdu Building Room 1701, 126 Nanguang Road; Guangdong, Shenzhen, , China

Moderate Risk

FDA Import Risk Assessment

35.6

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

4/16/2015

Latest Refusal

8/8/2011

Earliest Refusal

Score Breakdown

Violation Severity

53.2×40%

Refusal Volume

38.6×30%

Recency

0.0×20%

Frequency

27.1×10%

How is this score calculated?

Proprietary Algorithm

40% Violation Severity — AI-assessed (1-10)
30% Refusal Volume — Logarithmic scale
20% Recency — Decays over 5 years
10% Frequency — Refusals per year

Violation Summary

1189×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

3418×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

5087×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

474×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

1261×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

4761×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

Refusal History

Date	Product	Violations	Division
4/16/2015	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
10/2/2013	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
6/20/2013	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 3280FRNMFGREG 341REGISTERED	Cincinnati District Office (CIN-DO)
5/30/2013	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 476NO REGISTR 508NO 510(K)	Los Angeles District Office (LOS-DO)
2/21/2013	79OYWFOR THE REMOVAL OF FAT THROUGH LASER LIPOLYSIS	118NOT LISTED 341REGISTERED 47NON STD 508NO 510(K)	Los Angeles District Office (LOS-DO)
2/20/2013	95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL	47NON STD	Los Angeles District Office (LOS-DO)
12/27/2012	79NRJULTRASOUND, SKIN PERMEATION	118NOT LISTED 341REGISTERED 47NON STD 508NO 510(K)	Los Angeles District Office (LOS-DO)
12/27/2012	79NUVMASSAGER, VACCUUM, LIGHT INDUCED HEATING	118NOT LISTED 126FAILS STD 341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
6/21/2012	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 341REGISTERED 47NON STD 508NO 510(K)	Los Angeles District Office (LOS-DO)
8/8/2011	79GFEBRUSH, DERMABRASION	118NOT LISTED 341REGISTERED	Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Mychway Co. Ltd.'s FDA import refusal history?

Mychway Co. Ltd. (FEI: 3009052317) has 10 FDA import refusal record(s) in our database, spanning from 8/8/2011 to 4/16/2015.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Mychway Co. Ltd.'s FEI number is 3009052317.

What types of violations has Mychway Co. Ltd. received?

Mychway Co. Ltd. has been cited for 7 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Mychway Co. Ltd. come from?

All FDA import refusal data for Mychway Co. Ltd. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.