FDA UDI
In Commercial Distribution
🇺🇸 United States
SwallowStim Classic
DI: B736465731
·
Model: 01GS25
·
SPECTRAMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SwallowStim Classic
- Primary DI
- B736465731
- Version / Model
- 01GS25
- Catalog Number
- 01GS25
- Company Name
- SPECTRAMED, INC.
- Labeler DUNS
- 793161472
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-15
- Public Version
- 5
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- 09a7475f-43b2-4fcc-bf97-9a2a4ffe253f
Device Description
2-channel neuromuscular stimulation device. Handheld, Portable and battery powered by 4 AA Alkaline batteries. Maximum device output 50mA peak to peak with 1 pre-set program
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
- Yes
- 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 |
|---|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | Physical Medicine | 890.5850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46573 | Physical therapy transcutaneous neuromuscular electrical stimulation system | An electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B736465731 | HIBCC |
Customer Contacts
- Phone
- 1-800-643-1917
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K120922 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 0.46875 | Pound | |
| Width | 2.6 | Inch | |
| Length | 5 | Inch | |
| Depth | 1.1 | Inch |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -6 – 131 Degrees Fahrenheit
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 101.3 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity