510(k) K201982
K201982 is an FDA 510(k) premarket notification submitted by Foshan Hongfeng Co., Ltd. for the device "Air compression therapy system FO-3001; Air compression therapy system FO-3008". The FDA issued a decision of Substantially Equivalent on Mar 25, 2021. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650. Foshan Hongfeng Co., Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 25, 2021
- Date Received
- Jul 17, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Massager, Powered Inflatable Tube
- Device Class
- Class II
- Regulation Number
- 890.5650
- Review Panel
- PM
- Submission Type
- 510(k)