Clearance Summary
STRESS HANDLER received FDA 510(k) clearance under submission number K936148, sponsored by Arocep Enterprises , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1994-04-21.
- Submission: K936148
- Applicant / Sponsor: Arocep Enterprises , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5660
- Decision date: 1994-04-21
Classification & Regulation
This clearance is catalogued under FDA product code LYG and 21 CFR 890.5660, within the Physical Medicine review panel as a Class I device.