510(k) K213655
- Device
- HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)
- Applicant
- Hilltek, LLC
- 510(k) number
- K213655
- Product code
- IPF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-01-17
- Date received
- 2021-11-19
- Regulation
- 890.5850
- Classification name
- Stimulator, Muscle, Powered
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Mohammadali Nezakati
- Address
- 421 S Brookhurst St.; Suite 142 Anaheim CA US 92804 92804
FDA Registration Numbers
- 2031823
- 3010511300
- 3027718340
- 3012981024
- 1721293
- 9680487
- 3005868392
- 3015619973
- 3038197172
- 1644243
- 3033530347
- 3035374386
- 3003631667
- 3020683829
- 3022631685
- 3043657394
- 3010805941
- 9616877
- 3032062344
- 3038295706
- 3010583453
- 3010362721
- 3030151584
- 3004753827
- 3038138457
- 3009494725
- 3008048783
- 3012352782
- 8022189
- 3015588280
- 1055808
- 3011197543
- 3006850006
- 3017866822
- 3013671142
- 3004081884
- 3004733458
- 2024292
- 9612147
- 3013069546
- 3043153468
- 3015452693
- 3017936974
- 3014314933
- 3007731000
- 2026803
- 9616086
- 3027241812
- 1528764
- 3005621440
- 3019055598
- 9613347
- 3013375723
- 9710616
- 3010078417
- 3025235024
- 9710582
- 3007502541
- 1061158
- 1911273
- 3014315574
- 3004264602
- 3011782009
- 3023330992
- 3012386142
- 3008008477
- 3016670292
- 3005344585
- 8022890
- 3009437400
- 3031233199
- 3005095860
- 3043011436
- 3003740945
- 9613462
- 3013401749
- 3007543044
- 3005545216
- 9710580
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04260364812077 | HiTop 1touch | gbo Medizintechnik AG | 2024-08-05 |
| 04260364812060 | HiTop 2touch | gbo Medizintechnik AG | 2024-08-05 |
| 04260364812053 | HiTop 4touch | gbo Medizintechnik AG | 2024-08-05 |
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| K230701 | Stim2Go | PAJUNK GmbH Medizintechnologie | 2023-11-24 |
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| K223802 | accufit | Mettler Electronics Corporation | 2023-10-06 |