Clearance Summary
HUBANG, MODEL HBL13/HBG12-S received FDA 510(k) clearance under submission number K083044, sponsored by Shanghai Hubang Medical Appliances Co., 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 2008-12-12.
- Submission: K083044
- Applicant / Sponsor: Shanghai Hubang Medical Appliances Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3850
- Decision date: 2008-12-12
Classification & Regulation
This clearance is catalogued under FDA product code IOR and 21 CFR 890.3850, within the Physical Medicine review panel as a Class I device.