510(k) K883357
K883357 is an FDA 510(k) premarket notification submitted by Excel Medical Products, Inc. for the device "MODEL 1080 ROLLER MASSAGE TABLE". The FDA issued a decision of Substantially Equivalent on August 23, 1988. The device falls under product code JFB (Table, Physical Therapy, Multi Function), a Class II device regulated under 21 CFR 890.5880. Excel Medical Products, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 23, 1988
- Date Received
- August 9, 1988
- 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