Pulsed electromagnetic field wrap
FDA 510(k) K202337 · Hi-Dow International, Inc.
510(k) numberK202337
Submission
- Device name
- Pulsed electromagnetic field wrap
- Applicant
- Hi-Dow International, Inc.
Maryland Heights, MO, US - Received
- August 17, 2020
- Decision date
- December 15, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- ILX – Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5290
- Specialty
- Physical Medicine
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| K121338 | ZeobiILX · Special | Ivivi Health Science, LLC | 07/27/2012SE |
| K091791 | Provant System, Model 4201ILX · Traditional | Regenesis Biomedical, Inc. | 04/07/2010SE |
| K092044 | Orthocor Knee System, Median, Large, X-LargeILX · Traditional | Orthocor Medical | 12/18/2009SE |
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| K070541 | Ivivi Sofpulse, Models 912-M10, ROMA3 and Torino IIILX · Traditional | Ivivi Technologies, Inc. | 12/11/2008SE |
| K070931 | Model PMT850ILX · Traditional | Promedtek, Inc. | 05/24/2007SE |
More from Promedtek, Inc.
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|---|---|---|
| K233461 | Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)NUH · Traditional | 01/19/2024SE |
| K210383 | Wrap Accessory ElectrodesGXY · Traditional | 11/12/2021SE |
| K190617 | Wrap accessory electrodesGXY · Traditional | 07/02/2019SE |
| K163393 | Hi-Dow Wireless TENS/EMS System (Model HD-5N)NUH · Traditional | 08/04/2017SE |
| K102598 | Hi-Dow-XpNUH · Traditional | 05/13/2011SE |
Questions and answers
When was Pulsed electromagnetic field wrap cleared by the FDA?
Pulsed electromagnetic field wrap (K202337) received a 510(k) decision of Substantially Equivalent on December 15, 2020, 120 days after the submission was received.
What is the product code of K202337?
The FDA product code is ILX – Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat, a Class II (moderate risk) device regulated under 21 CFR 890.5290.