510(k) K173093
- Device
- TAMA BEMS Device
- Applicant
- TAMA Research Corporation
- 510(k) number
- K173093
- Product code
- NFO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-06-05
- Date received
- 2017-09-29
- Regulation
- 882.5890
- Classification name
- Stimulator, Transcutaneous Electrical, Aesthetic Purposes
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Ali Shambayati
- Address
- 7600 N. 16th St., Suite 205 Phoenix AZ US 85020 85020
FDA Registration Numbers#
- 3001236514
- 3019577501
- 3029083714
- 3038373471
- 3014737458
- 3007008050
- 3030052852
- 3026264
- 3017953405
- 3039394880
- 1832894
- 3023356343
- 3035785623
- 3007744197
- 3007554929
- 3010402752
- 3015542954
- 3007238544
- 3013689783
- 3017133271
- 3023339103
- 3030234086
- 3029740697
- 3010872290
- 3016413636
- 3035374386
- 3001224205
- 3012104022
- 3011883032
- 3011644607
- 3016076077
- 9616877
- 3033793026
- 3017060146
- 3027651556
- 3015286916
- 3033850491
- 3030541658
- 3043749884
- 3004832480
- 3012470925
- 3006982887
- 3005698910
- 3012386142
- 3008929787
- 3008345424
- 3029944286
- 3042261413
- 3004786509
- 3027645761
- 3021177911
- 3036720861
- 9616085
- 3004839404
- 3006459199
- 3037341611
- 8040537
Source Documents#
Other 510(k) Records For Product Code NFO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252621 | DeepSkin (DEP100) | El Global Trade, Ltd. | 2026-05-08 |
| K252146 | Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) | Shenzhen Siken 3D Technology Development Co., Ltd. | 2025-12-23 |
| K252187 | Aura Glide (FC40) | Aura Medical, LLC | 2025-12-23 |
| K250618 | Medi Lift Essential Eye Mask | Ya-Man, Ltd. | 2025-10-29 |
| K250227 | JOVS Electric Stimulation Beauty Device (JE2) | Shenzhen Qianyu Technology Co., Ltd. | 2025-10-17 |
| K251034 | Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand (HD-44) | Shenzhen Nuon Medical Equipment Co., Ltd. | 2025-10-12 |
| K252553 | Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) | Shenzhen Jianchao Intelligent Technology Co., Ltd. | 2025-10-09 |
| K251649 | Sunny Plus (Sunny) | ShenB Co., Ltd. | 2025-09-18 |
| K251909 | NeurotriS (SX2500); NeurotriS (SX3800) | A-1 Engineering | 2025-09-03 |
| K252218 | MF SC GEN2 Facial Toning System | Micro Current Technology, Inc. | 2025-07-18 |
| K244004 | Microcurrent Facial Device (CEC101, EE0101, EEI101) | Shenzhen Dachi Communication Co., Ltd. | 2025-07-10 |
| K250361 | SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1 | Geske Beauty Tech GmbH | 2025-05-23 |
| K243072 | Préime DermaFacial (MicroT) | EMA Aesthetics , Ltd. | 2025-04-01 |
| K243587 | PureLift GLOW | Xtreem Pulse, LLC | 2025-03-06 |
| K243063 | Myolight Microcurrent Handpiece | Raja Trading Company, Inc. | 2025-02-10 |
Legacy Summary#
summary
FDA Review#
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