Electric Scooter
by Anhui Jbh Medical Apparatus Co., Ltd
510(k) K212090
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK212090 | Date22 Apr 2022 | StatusActive |
Official records
- FDA 510(k) database K212090
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- INI
- FDA applicant
- Anhui Jbh Medical Apparatus Co., Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 890.3800
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
The Electric Scooter is a motorized 3-wheeled vehicle designed to assist individuals with mobility needs. It functions as a powered mobility device to facilitate travel for users.
This device is manufactured by Anhui Jbh Medical Apparatus Co., Ltd. and has received FDA 510(k) clearance. It is classified as a class 2 medical device under regulation number 890.3800.
Devices cleared under K212090
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| RANGER IVY FBC01 | FBC01 | 06973175530846 | — | On the market |
| VOCIC FDB05 | FDB05 | 06973175530433 | — | On the market |
Similar devices
Other devices filed under FDA product code INI (Vehicle, Motorized 3-Wheeled).
- Heartway Power Mobility Scooter by HEARTWAY MEDICAL PRODUCTS CO., LTD.
- TMC ELECTRICAL SCOOTER, EASY 411 by Tmc Technology Corp.
- Solax Electric Scooter (Model: S202261B) by Dongguan Prestige Sporting Goods Co., Ltd.
- REM 250 THREE WHEELED ELECTRIC CART by Royal Enterprises Manufacturing, Inc.
- C.T.M. MOBILITY SCOOTER MODEL # HS-320 by Warepalmy Enterprise, LLC (Usa)
- KUANN DAH, COOL TANK MOTORIZED SCOOTER, KS4L320 by Kuann Dah Industry Co., Ltd.
- LOTUS BLAKE ESTEEM SCOOTER by Letrix Power Hangzhou Pty, Ltd.
- TRI-ROLLS REAR WHEEL DRIVE POWERED SCOOTER by Invacare Corp.
- MEDLINE STRIDER MAXI 3 by MEDLINE INDUSTRIES, INC.
- BOOSTER LITE 3 MOTORIZED SCOOTER by Optimed Technologies, Inc.