FDA.reportPublic FDA data

n/a

Primary DI
00858308006237
Brand
n/a
Company
Ergonomic Products, Inc.
Model
S1A3
Catalog number
S1A3
Device description
EP 330 Heat & Massage Only - Seamless
Published
2022-09-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
NRUChair, Dental, Without Operative Unit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRUChair, Dental, Without Operative UnitDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858308006237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858308006237008583080062378583080062370858308006237

GMDN Terms#

Term, Definition table
TermDefinition
Dental chair, electricA mains electricity (AC-powered) device designed to support a patient in a seated position to facilitate dental examination, treatment, and/or minor surgery procedures. It is typically adjustable in height to enable healthcare staff to perform procedures while standing. It usually includes head and armrests, a reclining back that may be tilted from a vertical to a horizontal position, and has rotating capabilities; some types can be programmed to several standard positions. Devices intended for dental examination and/or treatment (e.g., lights, irrigation) may be attached as components of the chair, or stand separately as self-supported, wall- or ceiling-mounted units.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-30 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-866-488-4793equip@ergonmic-products.com

Regulatory Flags#

DUNS number
051194887
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858308006534Harmony Open Bay WorkstationD1H1D1H12025-04-15
00858308006527N/AD1F2D1F22023-06-06
00858308006510N/AD1F1D1F12023-01-03
00858308006435n/aD1C1D1C12022-09-07
00858308006336n/aD1D4D1D42022-08-19
00858308006343n/aD1D1D1D12022-08-19
00858308006350n/aD1D2D1D22022-08-19
00858308006367n/aD1E2D1E22022-08-19
00858308006374n/aD1E4D1E42022-09-07
00858308006381n/aD1E1D1E12022-08-19
00858308006398n/aD1B4D1B42022-08-19
00858308006404n/aD1B2D1B22022-09-07
00858308006411n/aD1E3D1E32022-08-19
00858308006428n/aL2A1L2A12022-09-07
00858308006442n/aS1A1S1A42022-09-07
00858308006459n/aS1A2S1A22022-09-07
00858308006466n/aS1A3S1A32022-09-07
00858308006473n/aS1A4S1A42022-09-07
00858308006480n/aD3A1D3A12022-09-07
00858308006497n/aD2A1D2A12022-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D125780MLB2Premium PlusPremium Plus (Dongguan) LimitedNRU2026-05-27
D125780MW2Premium PlusPremium Plus (Dongguan) LimitedNRU2026-05-27
D125780SLB2Premium PlusPremium Plus (Dongguan) LimitedNRU2026-05-27
D125780SW2Premium PlusPremium Plus (Dongguan) LimitedNRU2026-05-27
06971119541323Dental chair and accessoriesGuangdong JINME Medical Technology Co., Ltd.NRU2026-03-30
00841709121845MidmarkMIDMARK CORPORATIONNRU2026-03-18
00841336111288Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNRU2025-11-11
00841336108554Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNRU2025-11-11
00841336110199Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNRU2025-09-28
10194665008383A-decA-DEC, INC.NRU2025-09-18
D178A12H0Flight Dental SystemsFlight Dental Systems USA Inc.NRU2025-08-29
D178A6E0Flight Dental SystemsFlight Dental Systems USA Inc.NRU2025-08-29
06971119541316Dental chair and accessoriesGuangdong JINME Medical Technology Co., Ltd.NRU2025-07-15
06971119541880Dental chair and accessoriesGuangdong JINME Medical Technology Co., Ltd.NRU2025-07-15
06971119542375Dental chair and accessoriesGuangdong JINME Medical Technology Co., Ltd.NRU2025-07-15
10194665006587A-decA-DEC, INC.NRU2025-05-19
10194665006594A-decA-DEC, INC.NRU2025-05-19
08800266944368Luvis Chair (LC700C-chair only plus)DENTIS CO. ,LTDNRU2025-02-21
10194665007911A-decA-DEC, INC.NRU2025-01-24
D1355370DOME Innovation ChairDome, Inc.NRU2025-01-14
TQ26126151051Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151061Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151071Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151081Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151741Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151881Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151050Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151060Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151070Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151080Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09