FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CTM Power Chair
DI: 00852202007444
·
Model: HS-5600
·
C.T.M. HOMECARE PRODUCT, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CTM Power Chair
- Primary DI
- 00852202007444
- Version / Model
- HS-5600
- Company Name
- C.T.M. HOMECARE PRODUCT, INC.
- Labeler DUNS
- 043045660
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-12-27
- Public Version
- 3
- Public Version Date
- 2025-12-29
- Public Version Status
- Update
- Public Device Record Key
- 6d6a6f48-1532-4ca6-8ef0-f9daa0042911
- Distribution End Date
- 2020-12-31
Device Description
Heavy Duty Rear-Wheels-Operated Power Chair, Red/Blue/Silver
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| ITI | Wheelchair, Powered | Physical Medicine | 890.3860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41877 | Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible | A wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk (not bariatric) designed to be propelled by power from one or more electric motor(s). The electronic control of speed and direction are performed by the occupant of the device. The device cannot be folded or readily dismantled for transport. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00852202007444 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K002983 | 000 |