IPRClass I
Crutch
21 CFR 890.3150 / Physical Medicine
IPR is the FDA product code for Crutch, a class I device type, regulated under 21 CFR 890.3150. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and 5 recalls.
Classification record
- Product code
- IPR
- Device name
- Crutch
- Regulation
- 21 CFR 890.3150
- Device class
- Class I
- Review panel
- Physical Medicine
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- Yes
- Third party review eligible
- No
- Ingested clearances
- 4
- Ingested recalls
- 5
Clearances, product code IPR
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1979 | 1 |
| 1980 | 1 |
| 1982 | 1 |
Applicants with the most clearances
Product code IPR| Applicant | Clearances |
|---|---|
| Maddak, Inc. | 2 |
| Husa Folding Crutch Co., Inc. | 1 |
| Manuco Manufacturing Co., Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- A & i Industries Ltd
- Aht Enterprise Corporation
- Aikin Healthcare Co., Ltd
- Airway Surgical Appliances Ltd.
- Alex Orthopedic, Inc.
- Aligned as Designed, LLC
- Amis (Xiamen) Cultural Creativity Co., Ltd
- Anping Huakang Medical Products Factory
- Apex Health Care Mfg., Inc.
- ASP Global, LLC
- Avivo Life, LLC
- Better Medical Technology Co., Ltd.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
