510(k) K950400
K950400 is an FDA 510(k) premarket notification submitted by Ultrassage, Inc. for the device "HAND MASSAGE UNIT". The FDA issued a decision of Substantially Equivalent on March 30, 1995. The device falls under product code IRO (Vibrator, Therapeutic), a Class I device regulated under 21 CFR 890.5975. Ultrassage, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 30, 1995
- Date Received
- February 1, 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