510(k) K040031
K040031 is an FDA 510(k) premarket notification submitted by Ceragem Co., Ltd. for the device "CERAGEM-C THERMAL ACUPRESSURE MASSAGER". The FDA issued a decision of Substantially Equivalent on July 28, 2004. The device falls under product code JFB (Table, Physical Therapy, Multi Function), a Class II device regulated under 21 CFR 890.5880. Ceragem Co., Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 2004
- Date Received
- January 8, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table, Physical Therapy, Multi Function
- Device Class
- Class II
- Regulation Number
- 890.5880
- Review Panel
- PM
- Submission Type