FDA UDI
In Commercial Distribution
🇺🇸 United States
ActiGraph
DI: 00853048008015
·
Model: GT9X
·
ACTIGRAPH L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ActiGraph
- Primary DI
- 00853048008015
- Version / Model
- GT9X
- Company Name
- ACTIGRAPH L.L.C.
- Labeler DUNS
- 144830952
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-12-28
- Public Version
- 4
- Public Version Date
- 2020-03-05
- Public Version Status
- Update
- Public Device Record Key
- 19ec4403-6a51-4538-acb3-573d90ef1215
Device Description
The GT9X is a body worn device that measures and records physical movement associated with daily activity and sleep. The GT9X is intended for use in applications where quantifiable measurement and storage of physical movement is desired.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ISD | Exerciser, Measuring | Physical Medicine | 890.5360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36252 | Kinesiology ambulatory recorder | A battery-powered device designed to continuously measure and record a patient's kinetic activity during routine ambulation, including monitoring the motion of individual joints/limbs, typically to assess joint mobility, gait performance, and fall-risk or frailty (e.g., during post-surgery rehabilitation). It consists of a motion sensor(s) worn on the torso or a limb (e.g., thigh, calf, wrist, ankle) while performing normal daily activities, and a computing device/software to which body movement signals are transmitted for recording/analysis; it may also be attached to or integrated in an external limb prosthesis for activity monitoring. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00853048008015 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K080545 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -10 – 45 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 45 Degrees Celsius