SHRASTI PHYSIO DEVICES
⚠️ Moderate Risk
FEI: 3023489688 • New Delhi, Delhi • INDIA
FEI Number
3023489688
Location
New Delhi, Delhi
Country
INDIAAddress
1st Floor, 202 Bl, New 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.
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.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/24/2024 | 89IMGSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT | Division of Southeast Imports (DSEI) | |
| 9/7/2023 | 89PQYNONTHERMAL SHORTWAVE THERAPY DEVICE INDICATED FOR OVER THE COUNTER USE FOR THE TREATMENT OF PAIN | Division of Southeast Imports (DSEI) | |
| 4/17/2023 | 89IMGSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT | Division of Southeast Imports (DSEI) | |
| 11/23/2022 | 79MVFSYSTEM, LASER, PHOTODYNAMIC THERAPY | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SHRASTI PHYSIO DEVICES's FDA import refusal history?
SHRASTI PHYSIO DEVICES (FEI: 3023489688) has 4 FDA import refusal record(s) in our database, spanning from 11/23/2022 to 10/24/2024.
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. SHRASTI PHYSIO DEVICES's FEI number is 3023489688.
What types of violations has SHRASTI PHYSIO DEVICES received?
SHRASTI PHYSIO DEVICES 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 SHRASTI PHYSIO DEVICES come from?
All FDA import refusal data for SHRASTI PHYSIO DEVICES 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.