Tone Applicator AG608499A
Tone Applicator AG608499A is a Class II device made by Inmode MD, Ltd., cleared under FDA 510(k) K201285 on 5 Mar 2021 (1 earlier submission) and listed in FDA GUDID since 30 Oct 2022 (UDI-DI 07290016633566), 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 | Number07290016633566 | Date30 Oct 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK201285 | Date5 Mar 2021 | StatusActive |
Official records
- AccessGUDID record 07290016633566
- FDA 510(k) database K201285
- FDA 510(k) database K192249
Across registries
- FDA 510(k) K201285 decided 5 Mar 2021 Active
- FDA GUDID UDI-DI 07290016633566 listed 30 Oct 2022 Listed
Timeline
- Cleared FDA 510(k) K192249
- Cleared FDA 510(k) K201285
- Listed FDA GUDID 07290016633566
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Tone Applicator
- Generic name
- Transcutaneous electrical stimulation probe
- Model / Ref / Catalog
- AG608499A
- Primary DI / UDI-DI
- 07290016633566
- FDA product code
- GZL, IPF
- GMDN term
- Transcutaneous electrical stimulation probe
- Device class
- Class II
- Regulation number
- 882.1330, 890.5850
- GUDID distribution status
- In Commercial Distribution
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