510(k) K220500
Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fitness 42/3 TLT by Ergoline, Ergoline Vitality Hybrid Light 3, Ergoline Vitality Hybrid Light, Planet Fitness 50/4 HLT by Ergoline, Planet Fitness 46/3 HLT by Ergoline, Ergoline Vitality Pure Light 3, Ergoline Vitality Pure Light, Planet Fitness 50/4 PLT III by Ergoline, Planet Fitness 50/4 PLT by Ergoline, Planet Fitness 46/3 PLT by Ergoline, Planet Fitness 42/3 PLT by Ergoline by
Jk-Holding GmbH
— Product Code LEJ
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 1, 2022
- Date Received
- February 22, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Booth, Sun Tan
- Device Class
- Class II
- Regulation Number
- 878.4635
- Review Panel
- SU
- Submission Type