510(k) K950655
K950655 is an FDA 510(k) premarket notification submitted by Ultrassage, Inc. for the device "THERMO MASSAGE UNIT, ELEC. THERAPUTIC MASSAGES". The FDA issued a decision of SN on March 7, 1995. The device falls under product code ISA (Massager, Therapeutic, Electric), a Class I device regulated under 21 CFR 890.5660. Ultrassage, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- March 7, 1995
- Date Received
- February 1, 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