INI · Vehicle, Motorized 3-Wheeled · Chrysalis Intelligence

Device class

Class II

Regulation 890.3800

Total clearances

2020-12-21 → 2026-09-24

Last 12 months

Unique sponsors

Classification details

Medical specialty

Physical Medicine

Review panel

Regulation number

890.3800

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd	11	2	2026-08-10
Dongguan Prestige Sporting Goods Co., Ltd.	4	0	2021-05-10
Guangdong Prestige Technology Co., Ltd.	4	1	2025-12-23
Suzhou Master Machinery Manufacturing Co.,Ltd	3	0	2025-07-22
Intradin (Shanghai) Machinery Co., Ltd.	3	1	2025-11-21
Anhui Jbh Medical Apparatus Co., Ltd.	3	2	2026-09-24
Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.	3	2	2026-05-20
Dongguan Smarfody Mobility Technology Co., Ltd.	2	2	2026-01-29
Yongkang Yile Vehicle Co., Ltd.	2	0	2025-01-06
Taizhou Reach Technology Co., Ltd.	1	0	2025-05-14
Ningbo Baichen Medical Devices Co., Ltd.	1	1	2026-01-02
Nanjing Mijo Technology Co., Ltd.	1	1	2026-03-12
Zhejiang Seedream Medical Equipment Co., Ltd.	1	0	2025-01-23
Wuyi Aichi Industry and Trade Co., Ltd.	1	1	2026-04-22
Zhejiang Taotao Vehicle Co., Ltd.	1	1	2025-12-04
Heartway Medical Products Co., Ltd.	1	0	2022-10-12
Wuyi Aichi Industry & Trade Co., Ltd.	1	0	2025-05-07
Zhejiang Nysin Medical Co., Ltd.	1	1	2026-01-29
Suntech UK , Ltd.	1	0	2023-02-22
Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd.	1	1	2026-03-17
Nanjing Jin Bai HE Medical Apparatus Co., Ltd.	1	0	2021-06-25
Yongkang Ruihe Metal Product Co., Ltd.	1	1	2026-07-07
Lichtmega Technology Co., Ltd.	1	0	2024-12-20
Whill, Inc.	1	0	2025-01-06
Jochu Technology Co., Ltd.	1	1	2026-07-14

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
E1100	HCPCS	Semi-reclining wheelchair, fixed full length arms, swing away detachable elevating leg rests ✓ CMS-verified description	Medium	HCPCS code for three-wheeled motorized scooter
E1110	HCPCS	Semi-reclining wheelchair, detachable arms (desk or full length) elevating leg rest ✓ CMS-verified description	Medium	Alternative HCPCS for motorized three-wheeled vehicle

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-09-24	K261078	Anhui Jbh Medical Apparatus Co., Ltd.	Electric Scooter (FNS01,FNS03)
2026-09-19	K261859	Anhui JBH Medical Apparatus Co., Ltd.	Electric Scooter (FDB08, FDB08A, FDB12)
2026-08-10	K260176	Zhejiang Innuovo Rehabilitation Devices Co.,Ltd	Mobility Scooter (W3483, W3483A)
2026-08-10	K260094	Zhejiang Innuovo Rehabilitation Devices Co.,Ltd	Mobility Scooter (W3465, W3902 (S50 Carbon))
2026-07-14	K261232	Jochu Technology Co., Ltd.	IERO Mobility Scooter (IERO-01)
2026-07-07	K261163	Yongkang Ruihe Metal Product Co., Ltd.	Mobility Scooter (R200)
2026-06-08	K253257	Jiangsu Intco Medical Products Co., Ltd.	Virgo Mobility Scooter (Virgo-D,Virgo-F)
2026-06-03	K253600	Yurob Rehabilitation Medical Co., Ltd.	Scooter (YD-03)
2026-05-20	K260717	Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.	Mobility Scooter (Air Carbon)
2026-04-22	K260237	Wuyi Aichi Industry and Trade Co., Ltd.	Mobility Scooter (X-12, X-14, X-17)
2026-03-17	K252813	Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd.	Electrical Scooter (SM4226)
2026-03-12	K253936	Nanjing Mijo Technology Co., Ltd.	Power Mobility Scooter (MJMA01, MJMA02)
2026-02-23	K253631	Zhejiang Wei Ling New Energy Technology Co., Ltd.	Mobility Scooter (CL-Q3, CL-Q4)
2026-02-18	K253643	Shenzhen Zhimahuaerkai Technology Co., Ltd.	Mobility Scooter (S3)
2026-01-29	K252349	Dongguan Smarfody Mobility Technology Co., Ltd.	Electric Scooter (Mojo-T330)
2026-01-29	K252347	Dongguan Smarfody Mobility Technology Co., Ltd.	Electric Scooter (Mojo-T580)
2026-01-29	K252275	Zhejiang Nysin Medical Co., Ltd.	Electric Scooter (DDF100)
2026-01-09	K253075	Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.	Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0)
2026-01-02	K252817	Ningbo Baichen Medical Devices Co., Ltd.	Mobility Scooter (BC-MS310)
2025-12-23	K252835	Guangdong Prestige Technology Co., Ltd.	Electric Scooter (S202572J, S2060, M2089, S2050)
2025-12-04	K252588	Zhejiang Taotao Vehicle Co., Ltd.	Mobility Scooter (T5)
2025-11-21	K252590	Intradin (Shanghai) Machinery Co., Ltd.	Powered Mobility Scooter (PMS105, GUT177, GCAT047)
2025-10-06	K252502	Nanjing Kangni Smart Technology Co., Ltd.	Folding Mobility Scooter (KD101)
2025-09-30	K251799	Jiangsu Bangbang Intelligent Technology Co., Ltd.	Mobility Scooter (BBR-Q40-01); Mobility Scooter (BBR-Q40-02); Mobility Scooter (BBR-Q40-03); Mobility Scooter (BBR-Q40-04); Mobility Scooter (BBR-Q40-05); Mobility Scooter (BBR-Q40-06)
2025-07-22	K251638	Suzhou Master Machinery Manufacturing Co.,Ltd	Mobility Scooter (MS160C)