FDA UDI
In Commercial Distribution
🇺🇸 United States
Therabody
DI: 00810036059671
·
Model: RecoveryTherm Hot/Vibration Back
·
Therabody, Inc.
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Therabody
- Primary DI
- 00810036059671
- Version / Model
- RecoveryTherm Hot/Vibration Back
- Company Name
- Therabody, Inc.
- Labeler DUNS
- 080550811
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-06
- Public Version
- 2
- Public Version Date
- 2024-09-18
- Public Version Status
- Update
- Public Device Record Key
- 49719271-d081-4f6c-b057-2f02d27d6003
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| ISA | Massager, Therapeutic, Electric | Physical Medicine | 890.5660 | 1 |
| IRT | Pad, Heating, Powered | Physical Medicine | 890.5740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36560 | Hand-held electric massager | An electrically-powered device with a vibrating head, or pads, designed to be held in the hand and drawn across the area of the body/muscles to be treated. The vibrating head, or pads, may optionally be heated, and may be interchangeable with others of different size and shape. It is typically used for respiratory therapy or physiotherapy (e.g., help reduce muscular tension, arthritic pain or joint mobility) in the home and/or healthcare facility. | No | Active |
| 62194 | Electric pad localized-body heating system | An assembly of mains electricity (AC-powered) devices designed for the transcutaneous application of heat to a localized body site (e.g., joint, limb) to relieve musculoskeletal pain. It consists of an electric heating pad typically made of synthetic fabric materials, and a hand-held control unit used to regulate and monitor the heat. It is intended for use in the home or a clinical setting. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810036059671 | GS1 |