Hi-Dow International Inc.
Maryland Heights, MO, US
HI-DOW INTERNATIONAL INC. appears in FDA device records in Maryland Heights, MO. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Hi-Dow International Inc. between 2011 and 2024. The busiest year on record is 2011, with 1. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 1 |
| 2017 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233461 | Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A) | NUH | Substantially Equivalent | |
| K210383 | Wrap Accessory Electrodes | GXY | Substantially Equivalent | |
| K202337 | Pulsed electromagnetic field wrap | ILX | Substantially Equivalent | |
| K190617 | Wrap accessory electrodes | GXY | Substantially Equivalent | |
| K163393 | Hi-Dow Wireless TENS/EMS System (Model HD-5N) | NUH | Substantially Equivalent | |
| K102598 | HI-DOW-XP | NUH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003895865 | 3003895865 | HI-DOW INTERNATIONAL INC. | 2555 Metro Blvd, Maryland Heights, MO 63043 US | 2026 | and 5 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- ILXDiathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
- GXYElectrode, Cutaneous
- ILYLamp, Infrared, Therapeutic Heating
- KHAMask, Scavenging
- ISAMassager, Therapeutic, Electric
- LYGMassager, Therapeutic, Manual
- OSDMassager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature
- OEANon-Surgical Gown
- IQEOrthosis, Lumbar
- IMEPack, Hot Or Cold, Reusable
- LZAPolymer Patient Examination Glove
- MSHRespirator, Surgical
- IPFStimulator, Muscle, Powered
- NGXStimulator, Muscle, Powered, For Muscle Conditioning
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief
- NUHStimulator, Nerve, Transcutaneous, Over-The-Counter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain