GENIUS CHIP (SHEN ZHEN) LIMITED

⚠️ Moderate Risk

FEI: 3007872329 • Shenzhen • CHINA

FEI

FEI Number

3007872329

📍

Location

Shenzhen

🇨🇳

Country

CHINA

🏢

Address

Xuefu Road, Zhongrun Building A303, Nanshan District, Shenzhen, , China

Moderate Risk

FDA Import Risk Assessment

41.6

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

11/27/2012

Latest Refusal

11/29/2010

Earliest Refusal

Score Breakdown

Violation Severity

47.9×40%

Refusal Volume

46.5×30%

Recency

0.0×20%

Frequency

85.1×10%

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

34112×

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).

50810×

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.

1188×

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).

3336×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

1265×

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.

3201×

LACKS FIRM

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.

Refusal History

Date	Product	Violations	Division
11/27/2012	89NGXSTIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING	118NOT LISTED 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
10/6/2011	89ILYLAMP, INFRARED, THERAPEUTIC HEATING	341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
6/7/2011	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
6/7/2011	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
6/7/2011	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
3/10/2011	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	126FAILS STD 508NO 510(K)	Los Angeles District Office (LOS-DO)
3/10/2011	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	126FAILS STD 508NO 510(K)	Los Angeles District Office (LOS-DO)
3/10/2011	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	126FAILS STD 508NO 510(K)	Los Angeles District Office (LOS-DO)
3/10/2011	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	126FAILS STD 508NO 510(K)	Los Angeles District Office (LOS-DO)
3/10/2011	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	126FAILS STD 508NO 510(K)	Los Angeles District Office (LOS-DO)
11/29/2010	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 333LACKS FIRM 341REGISTERED	Los Angeles District Office (LOS-DO)
11/29/2010	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 333LACKS FIRM 341REGISTERED	Los Angeles District Office (LOS-DO)
11/29/2010	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 333LACKS FIRM 341REGISTERED	Los Angeles District Office (LOS-DO)
11/29/2010	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 333LACKS FIRM 341REGISTERED	Los Angeles District Office (LOS-DO)
11/29/2010	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 333LACKS FIRM 341REGISTERED	Los Angeles District Office (LOS-DO)
11/29/2010	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 333LACKS FIRM 341REGISTERED	Los Angeles District Office (LOS-DO)
11/29/2010	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 320LACKS FIRM 341REGISTERED	Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is GENIUS CHIP (SHEN ZHEN) LIMITED's FDA import refusal history?

GENIUS CHIP (SHEN ZHEN) LIMITED (FEI: 3007872329) has 17 FDA import refusal record(s) in our database, spanning from 11/29/2010 to 11/27/2012.

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. GENIUS CHIP (SHEN ZHEN) LIMITED's FEI number is 3007872329.

What types of violations has GENIUS CHIP (SHEN ZHEN) LIMITED received?

GENIUS CHIP (SHEN ZHEN) LIMITED has been cited for 6 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 GENIUS CHIP (SHEN ZHEN) LIMITED come from?

All FDA import refusal data for GENIUS CHIP (SHEN ZHEN) LIMITED 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.