DeviceSignal · 510(k) cleared
Shenzhen Osto Medical Technology Co.,Ltd
FDA 510(k) decision recorded 2026-09-06 · K261131 · Traditional 510(k)
Event510(k) cleared
Effective2026-09-06
DecisionSESE
On 2026-09-06 the FDA recorded a 510(k) clearance decision for Shenzhen Osto Medical Technology Co.,Ltd, for Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J…. Clearance K261131. Product code NUH. A clearance is a regulatory decision, not an endorsement of the device.
Reported facts
- 510(k) number
- K261131
- Applicant
- Shenzhen Osto Medical Technology Co.,Ltd
- Device
- Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-500G, AST-500F; AST-500N; AST- 500C, AST- 500K, AST-500A; AST-300E, AST-500M, AST- 500U, AST- 500D; AST- 500E.)
- Decided on
- 2026-09-06
- Received on
- 2026-04-06
- Decision
- SESE
- Clearance type
- Traditional
- Product code
- NUH
- Review days
- 153
Every field above is as fda_device_510k published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_510k
- Source record
K261131- Snapshot hash
20a5eca6af1b369a7deac34e4dde0974506cc835c24e3cb66b330d9671a11814- Source URL
- https://download.open.fda.gov/device/510k/device-510k-0001-of-0001.json.zip
- Observed
- 2026-09-15T12:38:10.708Z
- Transform
fda_device_510k_to_clearance v1- Event rule
fda_device_510k_cleared v1- Event key
e121221deb117c8738b734f1fc350ee9dfce848ba57929099df142090669470c- Signal type
device_clearance.granted
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)