FDA UDI
In Commercial Distribution
🇺🇸 United States
Action®
DI: 00089904002372
·
Model: Hand Exerciser
·
ACTION PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Action®
- Primary DI
- 00089904002372
- Version / Model
- Hand Exerciser
- Catalog Number
- 70003
- Company Name
- ACTION PRODUCTS, INC.
- Labeler DUNS
- 067543058
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-09
- Public Version
- 2
- Public Version Date
- 2022-04-08
- Public Version Status
- Update
- Public Device Record Key
- d528a781-f3a5-4e35-9512-f7e7967bcc28
Device Description
Soft Hand Exerciser
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| ION | Exerciser, Non-Measuring | Physical Medicine | 890.5370 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34200 | Finger/hand exerciser | A non-powered device intended primarily to strengthen the muscles of the fingers and hands through repetitive finger/hand motion against resistance from elasticity, density, magnetism, or other means. It is available in a variety of forms including handgrips (some types with individual buttons to work each finger independently), elastic balls and webs, putty, and hand-held devices with elastic bands. The device may also help improve finger/hand flexibility and coordination, and help improve wrist and forearm strength. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00089904002372 | GS1 |
Customer Contacts
- Phone
- 301.797.1414
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in clean, dry environment
- Type
- Special Storage Condition, Specify
- Special Conditions
- Minimal UV exposure