FDA.reportPublic FDA data

BTC - Medical Equipment

Primary DI
08050038700016
Brand
BTC - Medical Equipment
Company
BTC SRL
Model
EDGE P
Catalog number
9110501
Device description
EDGE P is the ultimate concept developed by BTC specifically designed for Podiatry and Pedicure. EDGE P is an innovative Examination/Procedure Chair with a modern design whose key words are: Solidity and Technical Innovation.
Published
2021-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GBBChair, Surgical, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBBChair, Surgical, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08050038700016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08050038700016080500387000168050038700016

GMDN Terms#

Term, Definition table
TermDefinition
Podiatric chair, electricA mains electricity (AC-powered) device designed to support a patient in a seated position and to facilitate foot examination, treatment, and/or minor surgery procedures. It is typically adjustable in height and includes armrests and a reclining back that may be tilted from a vertical to a horizontal position. It usually includes individual leg sections and footrests with lifting and rotating capabilities; some types can be programmed to several standard positions. Devices intended for foot examination and/or treatment may be attached as components of the chair (and may be operated using the chair controls), or stand separately as self-supported or wall-mounted units.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius45 Degrees Celsius
Storage Environment Temperature5 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+390542643664btcmed@btc-med.it

Regulatory Flags#

DUNS number
387634079
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08050038700009BTC - Medical EquipmentEDGE M91105002021-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08600155032011DexorRappo Robotics, Inc.GBB2026-05-16
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05999569240079Comfort DIGITERM Műszaki Fejlesztő, Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságGBB2026-03-24
05999569242202Comfort DIGITERM Műszaki Fejlesztő, Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságGBB2026-03-24
05999569242219Comfort DIGITERM Műszaki Fejlesztő, Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságGBB2026-03-24
05999569244213Comfort DIGITERM Műszaki Fejlesztő, Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságGBB2026-03-24
05999569245005DiacareDIGITERM Műszaki Fejlesztő, Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságGBB2026-03-24
07350136560217Pedal platformRini Ergoteknik ABGBB2026-03-24
M368ESC2EYESTMBX1HAUSTEDGF HEALTH PRODUCTS, INC.GBB2026-02-02
04049199006277SCHMITZSCHMITZ medical GmbHGBB2025-09-17
04049199006284SCHMITZSCHMITZ medical GmbHGBB2025-09-17
04049199006291SCHMITZSCHMITZ medical GmbHGBB2025-09-17
M368ESC2EYESTMB1HaustedGF HEALTH PRODUCTS, INC.GBB2025-08-21
04049199011608SCHMITZSCHMITZ medical GmbHGBB2025-08-14
00840183530372BR Surgical, LLCBR Surgical, LLCGBB2025-07-16
00840183530389BR Surgical, LLCBR Surgical, LLCGBB2025-07-16
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00841709123061MidmarkMIDMARK CORPORATIONGBB2025-06-04