The following data is part of a premarket notification filed by Anhui Jbh Medical Apparatus Co.,ltd with the FDA for Electric Scooter.
Device ID | K212090 |
510k Number | K212090 |
Device Name: | Electric Scooter |
Classification | Vehicle, Motorized 3-wheeled |
Applicant | Anhui JBH Medical Apparatus Co.,Ltd No.116 Qicang Road, Industrial Park Chuzhou, CN |
Contact | Dandan Yang |
Correspondent | Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Central Ave. Mingguang, CN Anhui |
Product Code | INI |
CFR Regulation Number | 890.3800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-07-06 |
Decision Date | 2022-04-22 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06973175530433 | K212090 | 000 |