510(k) K952916
K952916 is an FDA 510(k) premarket notification submitted by Kinsei Shiatsu, Inc. for the device "SHIATSU MASTER MASSAGER CUSHION". The FDA issued a decision of SN on August 28, 1995. The device falls under product code IRO (Vibrator, Therapeutic), a Class I device regulated under 21 CFR 890.5975. Kinsei Shiatsu, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- August 28, 1995
- Date Received
- June 26, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Vibrator, Therapeutic
- Device Class
- Class I
- Regulation Number
- 890.5975
- Review Panel
- PM
- Submission Type