DynaFlex (Foam) 2x2 DF2x2F
DynaFlex (Foam) 2x2 DF2x2F is a Class II device made by Dynatronics Corp., cleared under FDA 510(k) K130987 on 17 Jul 2013 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10660584000611), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10660584000611 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK130987 | Date17 Jul 2013 | StatusActive |
Official records
- AccessGUDID record 10660584000611
- FDA 510(k) database K130987
Across registries
- FDA 510(k) K130987 decided 17 Jul 2013 Active
- FDA GUDID UDI-DI 10660584000611 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K130987
- Listed FDA GUDID 10660584000611
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- DynaFlex (Foam) 2"x2"
- Generic name
- Transcutaneous electrical stimulation electrode, single-use
- Model / reference
- DF2x2F
- Primary DI / UDI-DI
- 10660584000611
- 510(k) Number
- FDA product code
- GXY
- GMDN term
- Transcutaneous electrical stimulation electrode, single-use
- Device class
- Class II
- Regulation number
- 882.1320
- GUDID distribution status
- In Commercial Distribution
- Size
- Area/Surface Area — 4 Square inch
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