510(k) K900674
K900674 is an FDA 510(k) premarket notification submitted by Bio-Tech Co. for the device "CONSTI-SSAGE VIBRATOR/MASSAGE". The FDA issued a decision of Substantially Equivalent on Mar 2, 1990. The device falls under product code ISA (Massager, Therapeutic, Electric), a Class I device regulated under 21 CFR 890.5660. Bio-Tech Co. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 2, 1990
- Date Received
- Feb 13, 1990
- 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
- 510(k) Exempt