U66 EMS— 510(k) K864558
Substantially Equivalent for Some IndicationsSuntec Health & Fitness Group, Inc.
FDA 510(k) clearance K864558 for U66 EMS, Substantially Equivalent for Some Indications on 1986-12-29. Applicant: Suntec Health & Fitness Group, Inc.. Device class: 2.
Clearance details
- Applicant
- Suntec Health & Fitness Group, Inc.
- Product code
- Code IPF
- Device class
- Class 2
- Regulation
- 21 CFR 890.5850
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- North Palm Beach, FL, US
Recent devices under product code IPF
view allMore clearances from Suntec Health & Fitness Group, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.