FDA.reportPublic FDA data

OSITO

Primary DI
06950940801592
Brand
OSITO
Company
Shenzhen Osto Technology Co.,Ltd.
Model
AST-2012A
Published
2021-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NGXStimulator, Muscle, Powered, For Muscle Conditioning
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGXStimulator, Muscle, Powered, For Muscle ConditioningPhysical Medicine2
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172834000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172834000Dual output digital therapy massagerShenzhen Osto Technology Co., Ltd.2018-09-06NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06950940801592PrimaryGS10
06950940801608Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06950940801592069509408015926950940801592
06950940801608069509408016086950940801608

GMDN Terms#

Term, Definition table
TermDefinition
Respiratory syncytial virus (RSV) immunoglobulin G (IgG)/IgM antibody IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to respiratory syncytial virus (RSV) in a clinical specimen.

Regulatory Flags#

DUNS number
528161684
Device count
500
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06950940802810N/AAST-6462025-12-19
06950940802827N/AAST-6222025-12-20
06950940802773N/AAST-2011A2025-12-10
06950940802766N/AAST-804A2025-09-19
06950940802698N/AAST-8042025-07-21
06950940802667N/AAST-300C2025-06-20
06950940802582N/AAST-802B2025-05-30
06950940802612N/AAST-2012A2025-05-30
06950940802568N/AAST-300W2025-04-25
06950940802575N/AAST-300W2025-04-25
06950940802490capillusAST-805A2025-03-15
06950940802506capillusAST-805A2025-03-15
06950940802476AuxolievAST-6032025-03-10
06950940802483AuxolievAST-6032025-03-10
06950940801264OSITOAST-300H2025-02-25
06950940801271OSITOAST-300H2025-02-25
06950940802452N/AAST-300H2025-02-15
06950940802469N/AAST-300H2025-02-15
06950940802391N/AAST-805A2025-02-10
06950940802407N/AAST-805A2025-02-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978452680085AUVONShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06978452680085AUVONShenzhen Jiantuo Electronics Co., LtdNGX2026-06-03
06978452680092AUVONShenzhen Jiantuo Electronics Co., LtdNGX2026-06-03
06978452680092AUVONShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06978452680108NURSALShenzhen Jiantuo Electronics Co., LtdNGX2026-06-03
06978452680108NURSALShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06971712722075MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-06-02
06971712722075MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-06-02
06971712726943MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-05-30
06971712726943MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-05-30
06971712722990SalityHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-05-28
06971712722990SalityHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-05-28
03770018808086actiTENSSUBLIMEDNGX2026-05-27
03770018808086actiTENSSUBLIMEDNUH2026-05-27
03770018808093actiTENSSUBLIMEDNUH2026-05-27
03770018808093actiTENSSUBLIMEDNGX2026-05-27
03770018808109actiTENSSUBLIMEDNUH2026-05-27
03770018808109actiTENSSUBLIMEDNGX2026-05-27
03770018808116actiTENSSUBLIMEDNUH2026-05-27
03770018808116actiTENSSUBLIMEDNGX2026-05-27
03770018808253actiTENS MiniSUBLIMEDNUH2026-05-27
03770018808253actiTENS MiniSUBLIMEDNGX2026-05-27
03770018808260actiTENS MiniSUBLIMEDNUH2026-05-27
03770018808260actiTENS MiniSUBLIMEDNGX2026-05-27
00199874125305Muscle StimulatorShenzhen Yiran Intelligence Co., Ltd.NGX2026-05-08
00194346404155EquateWAL-MART STORES, INC.NUH2026-05-01
00810060832851Venus NovaVenus Concept Inc.NGX2026-04-15
00810093080786PainPod Hi-Dow International IncorporatedNGX2025-12-09
00810093080793PainPod Hi-Dow International IncorporatedNGX2025-12-09
00810113683782ManaRecovery Stimulation System Manamed, Inc.NUH2025-10-03