K233461
- 510(k) number
- K233461
- Device name
- Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)
- Applicant
- Hi-Dow International, Inc. MO · US
- Product code
- NUH — Stimulator, Nerve, Transcutaneous, Over-The-Counter
- Decision date
- 2024-01-19
- Date received
- 2023-10-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K233461
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.