510(k) K061912
- Device
- FUSION
- Applicant
- BURKE, INC.
- 510(k) number
- K061912
- Product code
- INI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-08-01
- Date received
- 2006-07-06
- Regulation
- 890.3800
- Classification name
- Vehicle, Motorized 3-wheeled
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DUWAYNE E KRAMER, JR.
- Address
- 1800 Merriam Ln. Kansas City KS US 66106 66106
FDA Registration Numbers#
- 3026585646
- 3015992762
- 3042262539
- 3008717361
- 3006247243
- 9618009
- 2531465
- 3003882673
- 3019842343
- 3006541027
- 3013934051
- 3004142507
- 2531618
- 3016969129
- 3043153502
- 8043457
- 3007771912
- 1058069
- 9680333
- 3021071770
- 3007608806
- 3012538618
- 3019984611
- 3008841035
- 3038949386
- 3016068274
- 3017816603
- 3033905189
- 3007963811
- 3043105518
- 3004024088
- 3007675960
- 3044470904
- 1528161
- 3012425482
- 3017676057
- 3014983822
- 9616881
- 3009265647
- 3029926469
- 3012781455
- 3016733848
- 3004594214
- 3015726735
- 3034732597
- 9616873
- 3008812160
- 3013973449
- 1821729
- 3005619729
- 8043717
- 3011191255
- 3022982004
- 3037000105
- 3014489639
- 3008597995
- 3012521614
- 3020640553
- 3016195086
- 3030671633
- 3033860076
- 3032013112
- 3039857114
- 3035382637
- 3003636180
- 3034989977
- 3003820676
- 3020147377
- 3012604975
Source Documents#
Other 510(k) Records For Product Code INI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260717 | Mobility Scooter (Air Carbon) | Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. | 2026-05-20 |
| K260237 | Mobility Scooter (X-12, X-14, X-17) | Wuyi Aichi Industry and Trade Co., Ltd. | 2026-04-22 |
| K252813 | Electrical Scooter (SM4226) | Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd. | 2026-03-17 |
| K253936 | Power Mobility Scooter (MJMA01, MJMA02) | Nanjing Mijo Technology Co., Ltd. | 2026-03-12 |
| K253631 | Mobility Scooter (CL-Q3, CL-Q4) | Zhejiang Wei Ling New Energy Technology Co., Ltd. | 2026-02-23 |
| K253643 | Mobility Scooter (S3) | Shenzhen Zhimahuaerkai Technology Co., Ltd. | 2026-02-18 |
| K252349 | Electric Scooter (Mojo-T330) | Dongguan Smarfody Mobility Technology Co., Ltd. | 2026-01-29 |
| K252347 | Electric Scooter (Mojo-T580) | Dongguan Smarfody Mobility Technology Co., Ltd. | 2026-01-29 |
| K252275 | Electric Scooter (DDF100) | Zhejiang Nysin Medical Co., Ltd. | 2026-01-29 |
| K253075 | Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0) | Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. | 2026-01-09 |
| K252817 | Mobility Scooter (BC-MS310) | Ningbo Baichen Medical Devices Co., Ltd. | 2026-01-02 |
| K252835 | Electric Scooter (S202572J, S2060, M2089, S2050) | Guangdong Prestige Technology Co., Ltd. | 2025-12-23 |
| K252588 | Mobility Scooter (T5) | Zhejiang Taotao Vehicle Co., Ltd. | 2025-12-04 |
| K252590 | Powered Mobility Scooter (PMS105, GUT177, GCAT047) | Intradin (Shanghai) Machinery Co., Ltd. | 2025-11-21 |
| K252502 | Folding Mobility Scooter (KD101) | Nanjing Kangni Smart Technology Co., Ltd. | 2025-10-06 |
Legacy Summary#
summary
FDA Review#
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