510(k) K900356
K900356 is an FDA 510(k) premarket notification submitted by Life Enhancement Technologies, LLC for the device "THERMOAIRE SPLINT (TM) (TAS)". The FDA issued a decision of Substantially Equivalent on May 7, 1990. The device falls under product code ILO (Pack, Hot Or Cold, Water Circulating), a Class II device regulated under 21 CFR 890.5720. Life Enhancement Technologies, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 7, 1990
- Date Received
- January 25, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pack, Hot Or Cold, Water Circulating
- Device Class
- Class II
- Regulation Number
- 890.5720
- Review Panel
- PM
- Submission Type