510(k) K950321
K950321 is an FDA 510(k) premarket notification submitted by Kinsei Shiatsu, Inc. for the device "SHAPE UP MOMI ROLLER". The FDA issued a decision of SN on February 14, 1995. The device falls under product code ISA (Massager, Therapeutic, Electric), a Class I device regulated under 21 CFR 890.5660. Kinsei Shiatsu, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- February 14, 1995
- Date Received
- January 26, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Massager, Therapeutic, Electric
- Device Class
- Class I
- Regulation Number
- 890.5660
- Review Panel
- PM
- Submission Type