Amp Recover

Primary DI
00884400342027
Brand
Amp Recover
Company
AMP Health Inc.
Model
2.0
Device description
Amp Recover is a software as a medical device (SaMD) intended to support the physical rehabilitation of patients undergoing musculoskeletal recovery under the supervision of a licensed healthcare professional in the clinic or home environment. The system includes clinician-prescribed rehabilitation exercises for the upper and lower extremities delivered through a patient-facing mobile application with guided instruction and feedback, as well as remotely accessible patient performance metrics and patient-reported outcomes available to the medical professional through a provider-facing interface. Patient assessment, exercise prescription, and approval by the medical professional are required prior to use and throughout the course of therapy. Amp Recover is intended to support clinician-directed rehabilitation and does not independently diagnose medical conditions, prescribe treatment, or make autonomous clinical decisions.
Published
2026-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
QKCInteractive Rehabilitation Exercise Device, Prescription Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QKCInteractive Rehabilitation Exercise Device, Prescription UsePhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884400342027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884400342027008844003420278844003420270884400342027

GMDN Terms#

Term, Definition table
TermDefinition
Biomechanical function analysis/rehabilitation softwareA software package intended to be used by patients and clinicians to receive and display a patient’s physical exercise/movement/action data [e.g., kinesiology/gait data (walking speed or distance)] to facilitate analysis as part of physical assessment/rehabilitation. It is intended to be used while using an interactive rehabilitation system, biomechanical function analysis system and/or kinesiology recorder (ambulatory or implantable). It might be intended to function in conjunction with a motion-sensing system/device or limb-support robotic system, and may be capable of storing and/or enable viewing of patient performance data.

Regulatory Flags#

DUNS number
119350852
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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 Sharing Product Codes#

Primary DI, Brand, Company table
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07290020097040Kemtai CareKEMTAI LTDQKC2026-02-05
07290020097002Kemtai CareKEMTAI LTDQKC2025-12-23
07290020097019Kemtai CareKEMTAI LTDQKC2025-12-23
07290020097026Kemtai CareKEMTAI LTDQKC2025-12-23
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05065012458138Strolll RehabSTROLLL LIMITEDQKC2025-12-16
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00860011881728Proactive YouVIRTUSENSE TECHNOLOGIES, INC.QKC2025-12-01
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05391548420005VertigeniusDIGITAL REHABILITATION LIMITEDQKC2025-02-23
05391548420012VertigeniusDIGITAL REHABILITATION LIMITEDQKC2025-02-23
05391548420029VertigeniusDIGITAL REHABILITATION LIMITEDQKC2025-02-20
05391548420036VertigeniusDIGITAL REHABILITATION LIMITEDQKC2025-02-20
05065012458114Reality DTxSTROLLL LIMITEDQKC2024-07-08
05065012458121Reality DTxSTROLLL LIMITEDQKC2024-07-08
G629RESTORESKILLSTHERA0Restore Skills TherapyTIMOCCO USA, INC.QKC2024-06-27
00860011881704VSTBalanceVIRTUSENSE TECHNOLOGIES, INC.QKC2024-06-10
08809970060005EverEx RehabEverExQKC2024-04-03
00196852042524Motion TrainerTrainer Rx, Inc. D/B/A RecoveryoneQKC2023-08-29
05065012458039Reality DTxSTROLLL LIMITEDQKC2023-08-22
05065012458046Reality DTxSTROLLL LIMITEDQKC2023-08-22
05065010464001GaitSmart®DYNAMIC METRICS LIMITEDQKC2023-05-17