FDA.report

PLR995M

Primary DI
00606509401043
Brand
PLR995M
Company
PRIDE MOBILITY PRODUCTS CORPORATION
Model
PLR995M
Catalog number
N/A
Device description
An electric positioning chair is a device with a motorized positioning control that is intended for medical purposes and that can be adjusted to various positions. The device is used to provide stability for patients with athetosis (involuntary spasms) and to alter postural positions.
Published
2018-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
INOChair, Positioning, Electric

Product Code Classifications

CodeDeviceSpecialtyClass
INOChair, Positioning, ElectricPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00606509401043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00606509401043006065094010436065094010430606509401043

GMDN Terms

TermDefinition
Stand-up chair, electricA mains electricity (AC-powered) device designed to support a person with a disability (e.g., geriatric, injured, disabled) in a sitting posture and helps the person via its self-raising mechanism to both to sit down from a standing position and stand up from a sitting position. The electrically-powered features may include a seat that can be elevated and tilted forward to help the person stand, and/or a seat composed of several articulated sections that tilt to facilitate the person's activities and comfort. The device may also include other accessories or restraints according to the person's particular disabilities.

Sterilization Methods

Method

Regulatory Flags

DUNS number
041477449
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00606509500234MM3710MM3710N/A2022-07-22
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00606509100304EVO614HDEVO614HDN/A2022-01-04
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00606509700122Pro Seating Coolcore Cushion (PRO.111)Pro Seating Coolcore Cushion (PRO.111)N/A2021-09-28
00606509700139Pro Seating Coolcore Cushion (PRO.135)Pro Seating Coolcore Cushion (PRO.135)N/A2021-09-28
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00606509700153Pro Seating Coolcore Cushion (PRO.315)Pro Seating Coolcore Cushion (PRO.315)N/A2021-09-28
00606509700160Pro Seating Coolcore Cushion (PRO.345)Pro Seating Coolcore Cushion (PRO.345)N/A2021-09-28
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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00606509500418MM5401Pride Mobility Products CorpINO2026-02-03
00606509500425MM5640Pride Mobility Products CorpINO2026-02-03
B247PL102Chair, Electric PosiitioningGOLDEN BROTHERS, INC.INO2025-12-08
B247PL103Chair, Electric PosiitioningGOLDEN BROTHERS, INC.INO2025-12-08
B247PR104Chair, Electric PosiitioningGOLDEN BROTHERS, INC.INO2025-12-08
B247PR401Chair, Electric PosiitioningGOLDEN BROTHERS, INC.INO2025-12-08
B247PR446Chair, Electric PosiitioningGOLDEN BROTHERS, INC.INO2025-12-08
B247PR454Chair, Electric PosiitioningGOLDEN BROTHERS, INC.INO2025-12-08
B247PR455Chair, Electric PosiitioningGOLDEN BROTHERS, INC.INO2025-12-08
B247UC105Chair, Electric PosiitioningGOLDEN BROTHERS, INC.INO2025-12-08
B247UC464Chair, Electric PosiitioningGOLDEN BROTHERS, INC.INO2025-12-08
B247UC465Chair, Electric PosiitioningGOLDEN BROTHERS, INC.INO2025-12-08
B247UC476Chair, Electric PosiitioningGOLDEN BROTHERS, INC.INO2025-12-08
B247UC480Chair, Electric PosiitioningGOLDEN BROTHERS, INC.INO2025-12-08
00606509401685LC435PWPride Mobility Products CorpINO2025-11-14
00606509500401MM6420Pride Mobility Products CorpINO2025-09-05
B247PR519Chair, Electric PositioningGOLDEN BROTHERS, INC.INO2025-08-14
B247UC571Chair, Electric PosiitioningGOLDEN BROTHERS, INC.INO2025-08-14
B247PR511Chair, Electric PosiitioningGOLDEN BROTHERS, INC.INO2025-08-12
B247PR525Chair, Electric PosiitioningGOLDEN BROTHERS, INC.INO2025-08-12
B247PR527Chair, Electric PosiitioningGOLDEN BROTHERS, INC.INO2025-08-12
B247PR764Chair, Electric PosiitioningGOLDEN BROTHERS, INC.INO2025-08-12
00606509500395MM8955Pride Mobility Products CorpINO2025-08-07
00606509500326MM3600Pride Mobility Products CorpINO2025-08-05
00606509500371MM8945Pride Mobility Products CorpINO2025-08-05
B47PR511Chair, Electric PosiitioningGOLDEN BROTHERS, INC.INO2025-06-18
00606509401661LC435XLPride Mobility Products CorpINO2024-12-19
00606509401678LC435XXLPride Mobility Products CorpINO2024-12-19
00606509401654PLR5900Pride Mobility Products CorpINO2024-10-31
00606509401579LC475SPride Mobility Products CorpINO2024-09-13