Accord Medical Products Pvt. Ltd.
⚠️ Moderate Risk
FEI: 3010922122 • Delhi, Delhi • INDIA
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
© ImportRefusal.com Original Analysis
Violation Summary
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).
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.
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.
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).
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).
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 |
|---|---|---|---|
| 3/1/2021 | 84GXYELECTRODE, CUTANEOUS | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/1/2021 | 89IKDCABLE, ELECTRODE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/1/2021 | 89IMGSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/1/2021 | 89NYYSTIMULATOR, MUSCLE, POWERED, WITH LIMITED OUTPUT, FOR REHABILITATION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/28/2019 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of Southeast Imports (DSEI) | |
| 3/11/2019 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | Division of Southeast Imports (DSEI) | |
| 3/8/2019 | 89PHWCOLD PACK AND VIBRATING MASSAGER | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/6/2019 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of Southeast Imports (DSEI) | |
| 2/8/2019 | 89PHWCOLD PACK AND VIBRATING MASSAGER | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/30/2019 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of Southeast Imports (DSEI) | |
| 1/30/2019 | 84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | Division of Southeast Imports (DSEI) | |
| 1/30/2019 | 89IMGSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT | Division of Southeast Imports (DSEI) | |
| 1/30/2019 | 84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | Division of Southeast Imports (DSEI) | |
| 12/11/2018 | 89IROVIBRATOR, THERAPEUTIC | Division of Southeast Imports (DSEI) | |
| 12/3/2018 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of Southeast Imports (DSEI) | |
| 10/12/2018 | 89IMGSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT | Division of Southeast Imports (DSEI) | |
| 10/12/2018 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of Southeast Imports (DSEI) | |
| 9/21/2018 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of Southeast Imports (DSEI) | |
| 9/21/2018 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | Division of Southeast Imports (DSEI) | |
| 6/1/2018 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of Southeast Imports (DSEI) | |
| 5/17/2018 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of Southeast Imports (DSEI) | |
| 5/17/2018 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of Southeast Imports (DSEI) | |
| 5/17/2018 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of Southeast Imports (DSEI) | |
| 5/9/2018 | 89PHWCOLD PACK AND VIBRATING MASSAGER | Division of Southeast Imports (DSEI) | |
| 5/8/2018 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of Southeast Imports (DSEI) | |
| 4/30/2018 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | Division of Southeast Imports (DSEI) | |
| 4/20/2018 | 84NHINERVE, STIMULATOR, ELECTRICAL, PERCUTANEOUS (PENS) FOR PAIN RELIEF | Division of Southeast Imports (DSEI) | |
| 4/13/2018 | 84JXKCRANIAL ELECTROTHERAPY STIMULATOR TO TREAT DEPRESSION | Division of Southeast Imports (DSEI) | |
| 4/10/2018 | 89NYYSTIMULATOR, MUSCLE, POWERED, WITH LIMITED OUTPUT, FOR REHABILITATION | Division of Southeast Imports (DSEI) | |
| 3/29/2018 | 84JXKCRANIAL ELECTROTHERAPY STIMULATOR TO TREAT DEPRESSION | Division of Southeast Imports (DSEI) | |
| 3/16/2018 | 84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | Division of Southeast Imports (DSEI) | |
| 3/8/2018 | 84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | Division of Southeast Imports (DSEI) | |
| 3/8/2018 | 89NHNLAMP, NON-HEATING, FOR ADJUNCTIVE USE IN PAIN THERAPY | Division of Southeast Imports (DSEI) | |
| 3/8/2018 | 87LPQSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP | Division of Southeast Imports (DSEI) | |
| 3/2/2018 | 84NYWSTIMULATOR, NERVE, ELECTRICAL, TRANSCUTANEOUS, WITH LIMITED OUTPUT, FOR PAIN RELIEF | Division of Southeast Imports (DSEI) | |
| 3/2/2018 | 87LPQSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP | Division of Southeast Imports (DSEI) | |
| 3/2/2018 | 89IPFSTIMULATOR, MUSCLE, POWERED | Division of Southeast Imports (DSEI) | |
| 2/22/2018 | 84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | Division of Southeast Imports (DSEI) | |
| 2/16/2018 | 89IMGSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT | Division of Southeast Imports (DSEI) | |
| 2/9/2018 | 84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | Division of Southeast Imports (DSEI) | |
| 1/9/2018 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | Division of Southeast Imports (DSEI) | |
| 1/9/2018 | 89IMGSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT | Division of Southeast Imports (DSEI) | |
| 12/28/2017 | 84JXKCRANIAL ELECTROTHERAPY STIMULATOR TO TREAT DEPRESSION | Division of Southeast Imports (DSEI) | |
| 8/24/2017 | 89IMGSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT | Division of Southeast Imports (DSEI) | |
| 8/9/2017 | 89PQYNONTHERMAL SHORTWAVE THERAPY DEVICE INDICATED FOR OVER THE COUNTER USE FOR THE TREATMENT OF PAIN | Division of Southeast Imports (DSEI) | |
| 8/4/2015 | 89ONHPOWERED LASER NON-THEMAL INSTRUMENT WITH NON-HEATING EFFECT FOR ADJUNCTIVE USE IN PATH THERAPY | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Accord Medical Products Pvt. Ltd.'s FDA import refusal history?
Accord Medical Products Pvt. Ltd. (FEI: 3010922122) has 46 FDA import refusal record(s) in our database, spanning from 8/4/2015 to 3/1/2021.
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 Products Pvt. Ltd.'s FEI number is 3010922122.
What types of violations has Accord Medical Products Pvt. Ltd. received?
Accord Medical Products Pvt. Ltd. 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 Accord Medical Products Pvt. Ltd. come from?
All FDA import refusal data for Accord Medical Products Pvt. 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.