Accord Medical Pro

⚠️ Moderate Risk

FEI: 3011131710 • New Delhi • INDIA

FEI

FEI Number

3011131710

📍

Location

New Delhi

🇮🇳

Country

INDIA

🏢

Address

315 Rg Complex 1, , New Delhi, , India

Moderate Risk

FDA Import Risk Assessment

41.4

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

8/31/2018

Latest Refusal

5/14/2015

Earliest Refusal

Score Breakdown

Violation Severity

57.3×40%

Refusal Volume

45.6×30%

Recency

0.0×20%

Frequency

48.5×10%

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

11816×

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).

328015×

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.

50815×

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.

2371×

NO PMA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).

471×

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.

Refusal History

Date	Product	Violations	Division
8/31/2018	89NYYSTIMULATOR, MUSCLE, POWERED, WITH LIMITED OUTPUT, FOR REHABILITATION	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
3/15/2018	87LPQSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
3/15/2018	89IMGSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
3/15/2018	89IMGSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
3/15/2018	89IMGSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
3/15/2018	89IMGSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
3/8/2018	84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
3/2/2018	87LPQSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP	118NOT LISTED 237NO PMA 3280FRNMFGREG	Division of Southeast Imports (DSEI)
2/26/2018	89IMGSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/8/2018	89NYYSTIMULATOR, MUSCLE, POWERED, WITH LIMITED OUTPUT, FOR REHABILITATION	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
1/17/2018	89IMGSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
12/18/2017	89IMGSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
8/24/2017	89IMGSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT	118NOT LISTED 3280FRNMFGREG 47NON STD 508NO 510(K)	Division of Southeast Imports (DSEI)
4/18/2017	90IYNSYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
4/18/2017	89IMGSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
5/14/2015	84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Detroit District Office (DET-DO)

Frequently Asked Questions

What is Accord Medical Pro's FDA import refusal history?

Accord Medical Pro (FEI: 3011131710) has 16 FDA import refusal record(s) in our database, spanning from 5/14/2015 to 8/31/2018.

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. Accord Medical Pro's FEI number is 3011131710.

What types of violations has Accord Medical Pro received?

Accord Medical Pro has been cited for 5 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 Accord Medical Pro come from?

All FDA import refusal data for Accord Medical Pro 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.