510(k) K120853
- Device
- NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT,
- Applicant
- BIONESS, INC.
- 510(k) number
- K120853
- Product code
- GZI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-04-20
- Date received
- 2012-03-21
- Regulation
- 882.5810
- Classification name
- Stimulator, Neuromuscular, External Functional
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KIM TOMPKINS
- Address
- 25103 Rye Canyon Loop Valencia CA US 91355 91355
FDA Registration Numbers#
- 3012316249
- 3017264244
- 3038197172
- 3005713796
- 3006141275
- 3013401749
- 2013558
- 3008008477
- 3005170249
- 1417592
- 8040537
- 3005344585
- 3012651177
- 3030418885
- 1721293
- 9611612
- 3027669735
- 3019822804
- 3008525454
- 3013927823
- 3019892999
- 2011115
- 3038295706
- 3010362721
- 3036471706
- 3009437400
- 3013503259
- 3044563261
- 3004076349
- 3004438577
- 3004733458
- 3005868392
- 9616086
- 3007502541
- 3020683829
- 3005694504
- 9617486
- 3007543044
Source Documents#
Other 510(k) Records For Product Code GZI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242704 | Synchrony (20-3000) | Synapse Biomedical, Inc. | 2025-06-05 |
| K243828 | CIONIC NEURAL SLEEVE (NS-200) | Cionic, Inc. | 2025-05-02 |
| K240632 | Neuvotion NeuStim NN-01 | Neuvotion, Inc. | 2024-11-22 |
| K233006 | MyndMove, MyndMove 2.0 | Myndtec, Inc. | 2024-06-25 |
| K230997 | EvoWalk 1.0 System | Evolution Devices, Inc. | 2023-12-28 |
| K221823 | Cionic Neural Sleeve NS-100 | Cionic | 2022-07-21 |
| K213925 | MyoCycle MC-2 (Home / Home + / Pro / Pro +) | Myolyn, LLC | 2022-04-25 |
| K212149 | MyndMove 2.0 | Myndtec, Inc. | 2022-03-03 |
| K213622 | Cionic Neural Sleeve NS-100 | Cionic | 2022-02-14 |
| K202110 | MStim Drop Model: LGT-233 | Guangzhou Longest Science & Technology Co., Ltd. | 2021-11-05 |
| K193276 | Nerve and Muscle Stimulator | Shenzhen Xft Medical Limited | 2020-09-23 |
| K200262 | L100 Go System | Bioness, Inc. | 2020-03-04 |
| K191587 | L360 Thigh System | Bioness, Inc. | 2019-09-12 |
| K190285 | L300 Go System | Bioness, Inc. | 2019-03-14 |
| K173682 | L300 Go System | Bioness, Inc. | 2018-03-09 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases