Identity
- Trade Name
- Harmony SHR™ FDA UDI
- Generic Name
- Assistive dynamic arm support system FDA UDI
- Device Name
- Harmony SHR™ is a bilateral upper extremity exoskeleton that works with a patient’s scapulohumeral rhythm (SHR) to enable natural, comprehensive arm and shoulder therapy for those living with neurological and musculoskeletal movement impairments. FDA UDI
- Model / Reference
- M1-00001 FDA UDI
- Description
- Harmony SHR™ is a bilateral upper extremity exoskeleton that works with a patient’s scapulohumeral rhythm (SHR) to enable natural, comprehensive arm and shoulder therapy for those living with neurological and musculoskeletal movement impairments. FDA UDI
Identifiers
- Catalog Number
- M1-00001 FDA UDI
- Primary DI / UDI-DI
- 00850039266003 FDA UDI
- FDA Product Code
- IKK FDA UDI
- GMDN Term
- Assistive dynamic arm support system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.1925 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
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Assistive dynamic arm support system
Harmony SHR™ by Harmonic Bionics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Assistive dynamic arm support system.
- Guardian Splint — BM KOREA CO., LTD · Class I
- LINK Endo-Model EVO Knee System — WALDEMAR LINK GmbH & Co. KG · Class II
- Guardian Splint — BM KOREA CO., LTD · Class I
- Guardian Splint — BM KOREA CO., LTD · Class I
- Guardian Splint — BM KOREA CO., LTD · Class I
- Well at Walgreens — WALGREEN CO. · Class I
- Well at Walgreens — WALGREEN CO. · Class I
- Guardian Splint — BM KOREA CO., LTD · Class I
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
- Harmonic Bionics, Inc.
Sources (1)
- FDA UDI af32370d-d0d0-46d7-8b22-bcddd887220a 35 fields · synced May 30, 2026