Pulsed electromagnetic field wrap
510(k) K202337
Pulsed electromagnetic field wrap is a Class II device made by Hi-Dow International, Inc., cleared under FDA 510(k) K202337 on 15 Dec 2020, active as of 10 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK202337 | Date15 Dec 2020 | StatusActive |
Official records
- FDA 510(k) database K202337
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ILX
- Device class
- Class II
- Regulation
- 21 CFR Part 890.5290
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K202337
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| TrueStim HD-08A(TSG-A1) | HD-08A(TSG-A1) | 00851640007900 | — | On the market |
| TrueStim HD-08B(TSG-B1) | HD-08B(TSG-B1) | 00851640007917 | — | On the market |
| TrueStim HD-08B(TSG-E1) | HD-08B(TSG-E1) | 00081009308007 | — | On the market |
| TrueStim HD-08C(TSG-C1) | HD-08C(TSG-C1) | 00851640007924 | — | On the market |
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