FDA Registration
Active
🇺🇸 United States
HI-DOW INTERNATIONAL INC.
Reg #: 3003895865
·
FEI: 3003895865
·
Expires 2026
Products
15
Proprietary Names
18
Establishment Types
1
Classifications
15
Registration Details
- Registration Name
- HI-DOW INTERNATIONAL INC.
- Registration Number
- 3003895865
- FEI Number
- 3003895865
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2555 Metro Blvd
- City
- Maryland Heights
- State
- MO
- ZIP
- 63043
- Country
- US
Regulatory Submissions
- 510(k) Number
- K151693
Owner / Operator
- Firm Name
- Hi-Dow International Incorporated
- Operator Number
- 9052765
- Address
- 2555 Metro Blvd, --
- City
- Maryland Heights
- State
- MO
- Postal Code
- 63043
- Country
- US
- Correspondent
- Eric Y Chen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2020-12-16 |
| Massager, Therapeutic, Manual | LYG | Class 1 | Physical Medicine | No | 2013-06-24 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2020-12-16 |
| Mask, Scavenging | KHA | Class 1 | Anesthesiology | No | 2020-03-22 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2024-03-21 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-04-09 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2024-02-02 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2002-08-29 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2011-12-19 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2020-03-20 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2020-06-30 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2020-02-26 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2020-02-26 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2019-08-08 |
| Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature | OSD | Class 2 | Physical Medicine | No | 2013-06-23 |
Proprietary Names
Face Mask
Pack, hot or cold, reusable
Non-surgical isolation gown
LED therapeutic torch
MASSAGE MOUSE)
ECHO Massager
Electric Massager
Percussion Massager & Massage Gun
MULTIPLE(SBS
Hidow TENS/EMS
Painpod 3
Surgical N95 Respirator
Hidow/Epic Health N95 Surgical Face Mask
Disposable Medical Mask
Disposable Face Mask
Pro-Touch Wireless 6-12
PainPod ultra
Nitrile Powder Free Examination Gloves
Establishment Types
Complaint File Establishment per 21 CFR 820.198