510(k) K860837
K860837 is an FDA 510(k) premarket notification submitted by Ted Hoyer & Co., Inc. for the device "HOYER ONE-TOUCH POWER LIFTER". The FDA issued a decision of Substantially Equivalent on March 27, 1986. The device falls under product code FSA (Lift, Patient, Non-Ac-Powered), a Class I device regulated under 21 CFR 880.5510. Ted Hoyer & Co., Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 27, 1986
- Date Received
- March 5, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lift, Patient, Non-Ac-Powered
- Device Class
- Class I
- Regulation Number
- 880.5510
- Review Panel
- HO
- Submission Type