Identity
- Trade Name
- Guardian Unity FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- 2-channel neuromuscular stimulation device. Handheld, Portable and battery powered by 4 AA Alkaline batteries. Maximum device output 90mA with 7 pre-set programs FDA UDI
- Model / Reference
- 01GS90 FDA UDI
- Description
- 2-channel neuromuscular stimulation device. Handheld, Portable and battery powered by 4 AA Alkaline batteries. Maximum device output 90mA with 7 pre-set programs FDA UDI
Identifiers
- Catalog Number
- 01GS90 FDA UDI
- Primary DI / UDI-DI
- B73643211 FDA UDI
- 510(k) Number
- K020637 FDA UDI
- FDA Product Code
- IPF FDA UDI
- GMDN Term
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Depth — 1.1 Inch FDA UDILength — 5 Inch FDA UDIWidth — 2.6 Inch FDA UDIWeight — 0.46875 Pound FDA UDI
Category: Physical therapy transcutaneous neuromuscular electrical stimulation system
Guardian Unity by Spectramed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Spectramed, Inc.
Sources (1)
- FDA UDI 773fe51f-005d-401d-abde-ba7f88116a77 38 fields · synced May 30, 2026