Identity
- Trade Name
- ReGrasp FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- ReGrasp Electrode Positioning Kit Version 2 FDA UDI
- Model / Reference
- HSEPKV2 FDA UDI
- Description
- ReGrasp Electrode Positioning Kit Version 2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 17540176030147 FDA UDI
- 510(k) Number
- K153163 FDA UDI
- FDA Product Code
- GZI FDA UDIIPF FDA UDI
- GMDN Term
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5810 FDA UDI890.5850 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Physical therapy transcutaneous neuromuscular electrical stimulation system
ReGrasp by Rehabtronics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K153163 also covers:
- ReGrasp — Rehabtronics, Inc.
- ReGrasp — Rehabtronics, Inc.
- ReGrasp — Rehabtronics, Inc.
- ReGrasp — Rehabtronics, Inc.
- ReGrasp — Rehabtronics, Inc.
- ReGrasp — Rehabtronics, Inc.
- ReGrasp — Rehabtronics, Inc.
- ReGrasp — Rehabtronics, Inc.
- ReGrasp — Rehabtronics, Inc.
- ReGrasp — Rehabtronics, Inc.
- ReGrasp — Rehabtronics, Inc.
- ReGrasp — Rehabtronics, Inc.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Rehabtronics, Inc.
Sources (1)
- FDA UDI d4b60bf7-9bfa-4a66-a806-435188dbe35a 34 fields · synced Jun 8, 2026