FDA.reportPublic FDA data

MONTANE ANDES M-P7.F4 [SZER 76 CM]

Primary DI
05903684802319
Brand
MONTANE ANDES M-P7.F4 [SZER 76 CM]
Company
MEDEN INMED SP Z O O
Model
01-STO-3025-005
Catalog number
3573XL
Device description
The TERAPEUTA massage table is designed to be used in administration of the manual therapy techniques and physiotherapy to heal or provide relief in injuries or other impairments by restoring or improving the functions of the tissues, organs and systems.
Published
2023-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
INQTable, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INQTable, PoweredPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05903684802319PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05903684802319059036848023195903684802319

GMDN Terms#

Term, Definition table
TermDefinition
Massage table/couch, non-powered, portableA manually-adjusted, portable table designed for various kinds of complementary therapy (e.g., massage, acupuncture, aromatherapy, reflexology, kinesiology). It consists of a foldable framework (table top and legs) with a flat tabletop surface which may have a head section that can be manually adjusted. The height of the table may also be manually adjusted to fixed positions (i.e., set to an initial height but not readily adjustable). It may incorporate a face hole (the patients face fits into this when lying prone), a headrest, and an armrest(s). This device is typically known as a massage/therapy table, couch or bed.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height101Centimeter
Length201Centimeter
Width76Centimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
367142903
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05903684801671MONTANE ATLAS M-S3.F4 [SZER 69 CM]01-STO-3007-00135362022-11-04
05903684802074MONTANE ALPS M-P5.F4 [SZER 69 CM]01-STO-3023-00133582022-11-04
05903684801428MONTANE TATRAS M-S2.F0 [SZER 69 CM]01-STO-3002-00435202022-11-03
05903684801459MONTANE TATRAS M-S2.F4 [SZER 69 CM]01-STO-3003-00135232022-11-03
05903684801619MONTANE ATLAS M-S3.F0 [SZER. 69 CM]01-STO-3006-00135352022-11-03
05903684801251GALAXY TRACTION T3.F0 [SZER 70 CM] XL01-STO-3407-00532632023-11-15
05903684801299GALAXY TRACTION T3.F4 XL [SZER 70 CM]01-STO-3408-00532642023-11-15
05903684801381GALAXY TRACTION T4.F4 XL [SZER 70 CM] 01-STO-3424-00532672023-11-15
05903684803248TRITON 6 E (SZER. 69) 01-STO-3620-0024769E2023-11-06
05903684802142TRITON 6 E (SZER. 70) 01-STO-3620-0014769E2022-11-07
05903684803231TRITON 6 M (SZER. 70) 01-STO-3610-0024769M2022-11-07
05903684800315MONTANE TATRAS GERLACH E-S2.F4 [SZER. 69 CM]01-STO-3031-00135252022-11-04
05903684801756MONTANE ATLAS M-P3.F0 [SZER 69 CM]01-STO-3020-00435372022-11-04
05903684801787MONTANE ATLAS M-P3.F0 [SZER 69 CM] US01-STO-3020-00435322022-11-04
05903684801817MONTANE ATLAS M-P3.F4 [SZER 69 CM]01-STO-3021-001313622022-11-04
05903684801848MONTANE ATLAS M-P3.F4 [SZER 69 CM] US01-STO-3021-00435332022-11-04
05903684801879MONTANE ALPS M-S5.F0 [SZER. 69] 01-STO-3008-00135552022-11-04
05903684801909MONTANE ALPS M-S5.F0 [SZER. 69 CM] US01-STO-3008-00435502022-11-04
05903684801930MONTANE ALPS M-S5.F4 [SZER 69 CM] 01-STO-3009-00135562022-11-04
05903684801961MONTANE ALPS M-S5.F4 [SZER 69 CM] US01-STO-3009-00435512022-11-04

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