SPORT-ELEC BODY CONTROL SYSTEM— 510(k) K091865
Substantially EquivalentSport-Elec
FDA 510(k) clearance K091865 for SPORT-ELEC BODY CONTROL SYSTEM, Substantially Equivalent on 2009-11-13. Applicant: Sport-Elec. Device class: 2.
Clearance details
- Applicant
- Sport-Elec
- Product code
- Code NGX
- Device class
- Class 2
- Regulation
- 21 CFR 890.5850
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hampton, VA, US
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